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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

Metformin 500-1500 mg (open-label, as needed for rescue in LT)

The purpose of this clinical research study is to learn whether Saxagliptin can improve the body's ability to make its own insulin and lower blood sugar in people with type 2 diabetes

A study assessing Saxagliptin treatment in subjects with type 2 diabetes who are not controlled with diet and exercise

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period.  Also, subjects who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to receive open-label metformin added onto their blinded study medication

Tablet, Oral, 5 mg, Once daily, (up to 12 weeks ST, up to 104 weeks LT)

Tablet, Oral, 0 mg, Once daily (up to 12 weeks ST)

Tablet, Oral, 500 mg titrated to 1000 mg, Once daily (up to 104 weeks LT, starting at Week 12)

Tablets, Oral, 500-1500 mg, as needed (starting in LT)

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

Va San Diego Healthcare System

Diabetes & Glandular Disease Research Assoc,, Inc.

Pennington Biomedical Research Center

Mechanism of Action and Efficacy of Saxagliptin (BMS-477118) in the Treatment of Type 2 Diabetic Patients

Age Continuous

Gender, Male/Female

Race/Ethnicity, Customized

Region of Enrollment

Body Mass Index (BMI)

Study Specific Characteristic

Adjusted percent change in the insulin secretion rate AUC during a hyperglycemic clamp with an enteral glucose load [intravenous-oral hyperglycemic clamp (180-480 minutes)] at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.

Randomized participants with both a baseline and post-baseline value (up to Week 12).

Insulin Secretion Rate Area Under the Curve (AUC) During intravenous (IV)-oral Hyperglycemic Clamp - Percent Change From Baseline at Week 12

Adjusted percent change in the insulin secretion rate AUC during an intravenous hyperglycemic clamp (120-180 minutes) at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.

Randomized Participants with both a baseline and post-baseline value (up to Week 12).

Insulin Secretion Rate AUC During IV Hyperglycemic Clamp - Percent Change from Baseline at Week 12

At Least 1 AE

At Least 1 Related AE

Deaths

At Least 1 SAE

At Least 1 Related SAE

Discontinuations Due to SAEs

Discontinuations Due to AEs

AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.

Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period

Hemoglobin < 8 g/dL (n=0, 0)

Hematocrit < 0.75 x pre-Rx (n=0, 0)

Platelets < 50 x 10^9 c/L (n=0, 0)

Platelets > 1.5 x ULN (n=0, 0)

Leukocytes < 2 x 1000 c/uL (n=0, 0)

Neutrophils+Bands <1x1000 c/uL (n=18, 0)

Eosinophils >0.9x1000 c/uL (n=18, 0)

Lymphocytes <=0.75x1000 c/uL (n=18, 0)

ALP >3 x pre-Rx and >ULN (n=0, 0)

AST >3 x ULN (n=0, 0)

AST >5 x ULN (n=0, 0)

ALT >3 x ULN (n=0, 0)

ALT >5 x ULN (n=0, 0)

Bilirubin Total >2mg/dL (n=0, 0)

BUN >2 x pre-Rx and >ULN (n=0, 0)

Creatinine >2.5 mg/dL (n=0, 0)

Glucose, Serum Fasting < 50 mg/dL (n=0, 0)

Glucose, Serum Fasting > 500 mg/dL (n=0, 0)

Glucose, Serum Unspec. < 50 mg/dL (n=0, 0)

Glucose, Serum Unspec. > 500 mg/dL (n=0, 0)

Glucose, Plasma Fasting <50 mg/dL (n=0, 0)

Glucose,Plasma Fasting >500 mg/dL (n=0, 0)

Glucose, Plasma Unspec. <50 mg/dL (n=0, 0)

Glucose, Plasma Unspec. >500 mg/dL (n=18, 16)

Sodium, Serum Low (see description) (n=0, 0)

Sodium, Serum High (see description) (n=0, 0)

Potassium, Serum Low (see description) (n=0, 0)

Potassium, Serum High (see description) (n=0, 0)

Chloride < 90 mEq/L (n=0, 0)

Chloride > 120 mEq/L (n=0, 0)

Albumin < 0.9 LLN (n=0, 0)

Creatine Kinase > 5 x ULN (n=18, 16)

Uric Acid > 1.5 x ULN (n=0, 0)

Protein Urine, >=2-4 (n=0, 0)

Blood Urine >=2-4 (n=18, 0)

Red Blood Cells Urine >=2-4 (n=0, 0)

White Blood Cells Urine >=2-4 (n=0, 0)

A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; BUN=blood urea nitrogen; unspec.=unspecified; sodium serum low: <0.9 x Pre-Rx & <=130mEq/L / high: >1.1 x Pre-Rx & >=150mEq/L; potassium, serum low: <=0.8 x Pre-Rx & >=6.0mEq/L / high: 1.2 x Pre-Rx & >=6.0mEq/L; LLN=lower limit of normal.

Number of Participants Analyzed=Treated participants; n=number of treated subjects with baseline value and at least one value during the ST + LT treatment period.

Marked Laboratory Abnormalities - During ST + LT Treatment Period

12-Week Short-term Period

116-Week Short-term + Long-term Period

156 participants were enrolled in the study; 110 participants failed screening; 10 subjects entered lead-in and discontinued prior to randomization.

Arms	Assigned Interventions
Experimental: Saxagliptin (A) Metformin 500-1500 mg (open-label, as needed for rescue in LT)	Drug: Saxagliptin Tablet, Oral, 5 mg, Once daily, (up to 12 weeks ST, up to 104 weeks LT) Other Name: BMS-477118
Placebo Comparator: Placebo (ST) / Metformin (LT) (B) Metformin 500-1500 mg (open-label, as needed for rescue in LT)	Drug: Placebo Tablet, Oral, 0 mg, Once daily (up to 12 weeks ST) Drug: Metformin (blinded) Tablet, Oral, 500 mg titrated to 1000 mg, Once daily (up to 104 weeks LT, starting at Week 12) Drug: Metformin (open-label) Tablets, Oral, 500-1500 mg, as needed (starting in LT)

A study assessing Saxagliptin treatment in subjects with type 2 diabetes who are not controlled with diet and exercise

Official Title

Medical condition

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Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

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Date

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BMS Clinical Trials Disclosure

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

PhRMA posting

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