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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on diet and exercise alone. The safety of this treatment will also be studied

Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects with Type 2 Diabetes

NCT ID

Therapeutic Area

Tablets, Oral, Once Daily, Up to 24 weeks

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Local Institution

Dedicated Clinical Research

Richard  S. Cherlin, Md

Integris Family Care South

Southeastern Research Associates, Inc.

Internist Associates Of Central New York

Abbott Clinical Research Group, Inc

Stephen G. Danley, Do

Down East Medical Associates, Pa

Central Florida Clinical Trials, Inc.

Westside Center For Clinical Research

Southgate Medical Group

Panhandle Family Care Associates

James J. Brown, Md

Marina Raikhel, Md, Faafp

Clinical Research Advantage, Inc.

43rd Medical Associates, P.C.

Coastal Connecticut Research, Llc

Orange County Research Center

Belzoni Clinical Research

Capital Clinical Research Center

Endocrine Research Solutions, Inc.

Optimum Clinical Research, Inc.

R-Research

Avastra Clinical Trials

Valley Research

Family Physicians Of Greeley

A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel group, Phase III Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control with Diet and Exercise

Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Last Observation Carried Forward (LOCF) - All Randomized Participants

Age Continuous

Age, Customized

Female age less than equal to (<=) 50 years and greater than (>) 50 years.

Gender, Male/Female

Race/Ethnicity, Customized

Body Mass Index in Kg/m^2

Study Specific Characteristic

Hemoglobin A1c (HbA1c) %

Waist Circumference

All randomized participants who took at least one dose of double-blind study medication were included in the analysis.

Adjusted mean change in HbA1c from baseline at Week 24, or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available was determined(LOCF). HbA1c was measured as percent of hemoglobin by a central laboratory.  Data after rescue medication (metformin) was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c values were obtained at enrollment, lead-in, and at Day 1, Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.

N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.

Adjusted Mean Change from Baseline in Hemoglobin A1c (HbA1c) at Week 24 Last Observation Carried Forward (LOCF) - All Randomized Participants

Adjusted mean change in total body weight from baseline at Week 24, or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available LOCF was determined.  Data after rescue medication (metformin) was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight was measured in kilograms (kg) at qualification, lead-in, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 during double-blind period.

By applying sequential testing procedure, the testing was performed since the primary endpoint was significant.

Adjusted Mean Change from Baseline in Total Body Weight at Week 24 (LOCF) - Randomized Participants

Adjusted mean change in fasting plasma glucose (FPG)  from baseline at Week 24 (LOCF) was determined.  Data after rescue medication (metformin) was excluded from this analysis. FPG was measured as milligrams per deciliter (mg/dL) by a central laboratory at qualification, lead-in, Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 during double-blind period. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.

Number analyzed = Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.

Adjusted Mean Change from Baseline in Fasting Plasma Glucose at Week 24 (LOCF) - Randomized Participants

Liquid meal tolerance tests (MTTs) were scheduled to occur at Day 1 visit (MTT was to be completed 2 hours prior to first dose of treatment) and at Week 24 / End of treatment visit, or Rescue visit for participants meeting criteria for rescue due to lack of glycemic control.  At Week 24, study treatment was given 1 hour before MTT was administered. Participant fasted for at least 10 hours (h) prior to both visits and abstained from tobacco, alcohol, and caffeine for 24 h prior to the MTT. The liquid meal supplement was administered over 10 minutes, starting immediately after Time 0 blood sample was drawn. Blood samples for post-liquid meal Glucose were obtained at 30, 60, 120, and 180 minutes after ingesting the liquid supplement. Glucose was measured in milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of double-blind study medication.

Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 (LOCF) values.

Adjusted Mean Change from Baseline in Effect on 2-hour Post Liquid Meal Glucose at Week 24 (LOCF) - Randomized Participants

Therapeutic glycemic response was defined as HbA1c less than 7.0%. n=Number of participants with HBA1c less than (<) 7 % at Week 24, last observation carried forward (LOCF) while N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values.  Percent=n/N and was adjusted for Baseline HbA1c. Data after rescue medication (metformin) was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.

The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).

N=number of randomized participants with non-missing baseline and Week 24 (LOCF) values.

Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response at Week 24 (LOCF) - Randomized Participants

Adjusted mean waist circumference values from baseline to Week 24 (or the last post-baseline measurement prior to Week 24 if no Week 24 assessment was available, last observation  carried forward, (LOCF) was determined.  Data after rescue medication (metformin) was excluded from this analysis. Waist circumference was measured centimeters (cm) and obtained at lead-in, Day 1, and Week 24 of the double-blind period. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.

Following a sequential testing procedure, this comparison was not statistically tested, ie, the previous comparison did not meet the criterion for statistical significance.

Adjusted Mean Change from Baseline in Waist Circumference at Week 24 (LOCF) - Randomization Participants

Death

Serious Adverse Event (SAE)

Related SAE

Adverse Event (AE)

Related Adverse Event

Discontinued due to AE

Medical Dictionary for Regulatory Activities (MedDRA), version 12.1 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug as per the investigator. Baseline to last dose plus 4 days for AEs, plus 30 days for SAEs. Data after rescue included.

Participants who received at least 1 dose of double-blind study medication during the double-blind treatment period. Data after rescue were also included.

Number of Participants With Deaths, Serious AEs (SAEs), Adverse Events (AEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants

Cardiac Disorders AEs

Vascular Disorders AEs

Hypoglycemia AEs (excluding data after rescue)

Major hypoglycemic episode

Minor hypoglycemic episode

Other hypoglycemic episode

AE Suggestive of Genital Infection

AE Suggestive of UTI

AE of Renal Impairment (creatinine increased)

AE of Hypotension

AE of Fracture

AE of Urinary Stones

Participants with AEs of hypoglycemia, cardiac/vascular disorders, renal impairment or failure, volume depletion (hypotension/dehydration/hypovolemia), fractures, urinary stones, and other reports suggestive of genital infection or urinary tract infection (UTI) were summarized using MedDRA version 12.1. Data after rescue included for all AEs of special interest except hypoglycemia; hypoglycemia AEs were prior to rescue. Major hypoglycemic episode: symptomatic requiring 3rd party assistance due to severe impairment in consciousness or behavior with a glucose value < 54 mg/dL and prompt recovery after glucose/glucagon; Minor: either symptomatic with glucose measurement < 63 mg/dL, regardless of need for 3rd party assistance, or asymptomatic with glucose < 63 mg/dL that does not qualify as major; Other: suggestive but not meeting criteria for major or minor.

Randomized participants who received at least one dose of study medication in the double-blind period. Data after rescue included for all AEs of special interest except hypoglycemia; hypoglycemia AEs summarized below were prior to rescue.

Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants

Systolic Blood Pressure (n=65, 68, 65, 62)

Diastolic Blood Pressure (n=65, 68, 65, 62)

Blood pressure values were obtained on Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double blind period, after the participant was seated for quietly for 5 minutes; the same arm (right or left) was used consistently through out the study. Measurements were taken at least 10 hours after the last ingestion of caffeine, alcohol, or nicotine. Blood pressure was measured in millimeters of mercury (mmHg).  Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.

Participants who took at least 1 dose of double-blind study medication were analyzed. n= number of treated participants with non-missing baseline and Week 24 values.

Mean Change from Baseline in Seated Systolic and Diastolic Blood Pressure at Week 24, Including Data After Rescue  - Treated Participants

Heart rate values were obtained after the participant was seated for quietly for 5 minutes; the same arm (right or left) was used consistently through out the study. Measurements were taken at least 10 hours after the last ingestion of caffeine, alcohol, or nicotine. Heart rate was measured in beats per minute (bpm). Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.

N=number of participants who took at least 1 dose of double-blind study medication, with non missing baseline and Week 24 values.

Mean Change from Baseline in Seated Heart Rate at Week 24 - Treated Participants

Normal at BL, Normal at Week 24 (N=68, 72, 74, 68)

Abnormal BL, Normal at Week 24(N=68, 72, 74, 68)

Normal BL, Abnormal at Week 24(N=68, 72, 74, 68)

Abnormal BL, Abnormal at Week 24(N=68, 72, 74, 68)

Reported at BL, Not Reported at Week 24

12-Lead electrocardiograms (ECGs) were performed at Day -14 and Week 24/End of treatment visit (last observation carried forward) on participants who were supine. ECGs were assessed by the investigator. Baseline (BL) was Day -14 for this parameter.

N= Number of randomized participants, who took at least 1 dose of double-blind study medication, with non missing baseline (BL) and Week 24 (LOCF) values.

Number of Participants with Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Treated Participants

Hematocrit High >55% (N=68, 72, 74, 67)

Hemoglobin High >18 g/dL(N=68, 72, 74, 67)

Creatinine High >=1.5*PreRX(N=68, 72, 74, 67)

AST 3*ULN (N=68, 72, 74, 67)

ALT 3*ULN (N=68, 72, 74, 67)

ALT 5*ULN (N=68, 72, 74, 67)

AST or ALT >3*ULN (N=68, 72, 74, 67)

AST or ALT >5*ULN (N=68, 72, 74, 67)

Total bilirubin >1.5*ULN (N=68, 72, 74, 67)

Total bilirubin >2*ULN (N=68, 72, 74, 67)

ALP >1.5*ULN (N=68, 72, 74, 67)

ALP >3*ULN (N=68, 72, 74, 67)

Glucose >350 mg/dL (N=68, 72, 74, 67)

Creatinine Kinase > 5X ULN (N=68, 72, 74, 67)

Calcium <7.5 mg/dL (N=68, 72, 74, 67)

Calcium (mg/dL) >=1 vs ULN and  >=0.5 vs baseline

Potassium >= 6 meq/L (N=68, 72, 74, 67)

Magnesium <1 meq/L (N=68, 72, 74, 67)

Sodium <130 meq/L (N=68, 72, 74, 67)

Sodium >150 meq/L (N=68, 72, 74, 67)

Sodium < 120 meq/L

Safety laboratory measurements were obtained at Day 1, Weeks 1, 2, 4, 8, 12, 20, and 24 in the double blind Period. Baseline was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from baseline up to and including the last day of treatment plus 4 days. Data after rescue was also included. Abbreviations; Pretreatment (PreRX); grams per deciliter (g/dL); upper limit of normal (ULN); milliequivalent per liter (mEq/L); greater than (>) less than (<); Units per liter (U/L), alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP); blood urea nitrogen (BUN). Marked abnormality Low (High) defined: hemoglobin <6 (>18 females or >20 males) g/dL; hematocrit <20% ( >55% females or >60% males); BUN (>60 mg/dL) or Urea >21.4 mmol/L; creatinine (>=1.5*preRX,  >=2.5 mg/dL); AST and ALT >3*ULN; bilirubin >1.5*ULN; ALP >1.5*ULN.

N=Number of participants who received at least 1 dose of study medication and had non-missing laboratory results.

Number of Participants with Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants

Double Blind Treatment Period

Follow up Period  - No Drug Treatment

497 enrolled in Qualification Period: 297 completed: 13 withdrew consent, 1 lost to follow up (LTF), 1 pregnancy, 183 no longer met criteria, 2 other; 297 entered Placebo Lead-In Period: 282 completed: 3 withdrew consent, 4 LTF, 5 no longer met criteria, 3 other. 282 treated Double Blind; Follow Up visit: 4 weeks ± 5 days post treatment completion.

Arms	Assigned Interventions
Experimental: Dapagliflozin 1 mg Dapagliflozin: 1 mg	Drug: Dapagliflozin Tablets, Oral, Once Daily, Up to 24 weeks Other Name: BMS-512148 Other Name: Farxiga™
Experimental: Dapagliflozin 2.5 mg Dapagliflozin: 2.5 mg	Drug: Dapagliflozin Tablets, Oral, Once Daily, Up to 24 weeks Other Name: BMS-512148 Other Name: Farxiga™
Experimental: Dapagliflozin 5 mg Dapagliflozin: 5 mg	Drug: Dapagliflozin Tablets, Oral, Once Daily, Up to 24 weeks Other Name: BMS-512148 Other Name: Farxiga™
Placebo Comparator: Placebo Placebo: 0 mg	Drug: Placebo Tablets, Oral, Once Daily, Up to 24 weeks

Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects with Type 2 Diabetes

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

BMS Clinical Trials Disclosure

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator