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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

This study will evaluate the efficacy and tolerability of saxagliptin compared to glimepiride in elderly patients with type 2 diabetes mellitus who have inadequate glycaemic control on metformin monotherapy.

Saxagliptin compared to glimepiride in elderly type 2 diabetes patients, with inadequate glycemic control on metformin

1, 2, 3, 4 or 6 mg,  oral encapsulated tablet, once daily

Research Site

A 52-Week, Randomised, Double Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Compared to Glimepiride in Elderly Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycaemic Control on Metformin Monotherapy

Age Categorical

Age Continuous

Gender, Male/Female

Region of Enrollment

All patients

patients aged <75 years (n=217, n=216)

patients aged ≥75 years (n=142, n=143)

Defined as obtained on or before the 8th day after the last dosing day, as determined by central laboratory.  Safety analysis set.
Confirmed hypoglycaemia defined as: any event defined as either a symptomatic event with blood glucose level <3 mmol/L (<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement <3 mmol/L (<54 mg/dL).
Major (or severe) hypoglycaemia defined as: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level <3 mmol/L (<54 mg/dL), but with prompt recovery after glucose or glucagon administration.  These events may be associated with sufficient neuroglycopenia to induce seizure or coma.  Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration.

Safety analysis set (a subset of the randomised analysis set including patients who took at least one investigational product dose).

Proportion of patients reaching HbA1c <7% after 52 weeks of treatment without confirmed or severe hypoglycaemia.

Hypoglyceamic event defined as, Confirmed hypoglycaemia: any event defined as either a symptomatic event with blood glucose level <3 mmol/L (<54 mg/dL) and no need for external assistance, or an asymptomatic blood glucose measurement <3 mmol/L (<54 mg/dL).
Major (or severe) hypoglycaemia: symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with or without blood glucose level <3 mmol/L (<54 mg/dL), but with prompt recovery after glucose or glucagon administration.  These events may be associated with sufficient neuroglycopenia to induce seizure or coma.  Plasma glucose measurements may not be available during such an event, but neurological recovery, attributable to the restoration of plasma glucose to normal, was considered sufficient evidence that the event was induced by a low plasma glucose concentration. Safety analysis set.

Proportion of Patients Having Experienced at Least One Hypoglycaemic Event
(Confirmed or Severe) over the 52-week Double-blind Treatment Period.

Measured as the difference between the last on-treatment value (defined as obtained before or on the 8th day after the last dosing date), and the last pre-randomisation HbA1c value, as determined by central laboratory. Full analysis set.

The number of subjects with non-missing baseline and Week 52 (LOCF) values in the full analysis set (defined as the subset of patients in the randomized analysis set who took at least one randomised IP dose and have non-missing baseline and post-baseline efficacy data for at least one variable).

Change from baseline to week 52 in HbA1c.

Proportion of patients with their last on-treatment value (defined as obtained before or on the 8th day after the last dosing date), as determined by central laboratory, below the specified limits.  Full analysis set.

Proportion of patients achieving a therapeutic glycaemic response at Week 52 defined as HbA1c <7.0%

Measured as the difference between the last on-treatment value (defined as obtained before or on the first day after the last dosing date)and the last pre-randomisation fasting plasma glucose value, as determined by central laboratory.  Full analysis set.

Change from baseline to Week 52 in fasting plasma glucose (FPG)

Measured as the difference between the last on-treatment value (defined as obtained before or on the first day after the last dosing date) and the last pre-randomisation fasting plasma insulin value, as determined by central laboratory.  Full analysis set.

Change From Baseline to Week 52 in Insulin

β-cell function as estimated by the homeostasis model assessment (HOMA) model. Value is derived from FPG and fasting insulin; fasting insulin values below 2.074 μU/mL or above 57.595 μU/mL and FPG values below 3 mmol/L or above 25 mmol/L are excluded (as restricted by the calculation method used). Full analysis set.

Change from baseline to Week 52 in β-cell function (as measured by Homeostasis Model Assessment-β [HOMA-β]

Overall Study

A 2-week single-blind (to patient only) placebo lead-in period occurred from Week -2 to Week 0. Patients were from this period on,counselled on dietary and lifestyle modifications according to usual clinical routine. They were given a glucometer to check their plasma glucose at home at least every second day.

Arms	Assigned Interventions
Experimental: 1 Saxagliptin 5 mg	Drug: Saxagliptin 5 mg, oral tablet, once daily Other Name: Onglyza
Active Comparator: 2 Glimepiride 1 - 6 mg	Drug: Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily Other Name: Amaryl

Saxagliptin compared to glimepiride in elderly type 2 diabetes patients, with inadequate glycemic control on metformin - GENERATION

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

CSR-D1680L00002.pdf

D1680L00002_Clinical_Study_Protocol

Trial Results Summaries

Contacts

Contact