Diabetes Mellitus, Non-Insulin-Dependent
Conditions
Keywords
Type 2 Diabetes Mellitis
Brief summary
This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two AC2993 treatment arms or to placebo treatment and will continue with their required existing diabetes medications (metformin and a sulfonylurea) throughout the study.
Interventions
DRUGAC2993
Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
DRUGPlacebo
Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with Type 2 diabetes mellitus * Treated with both metformin and a sulfonylurea at defined doses for at least 3 months prior to screening * BMI= 27-45 kg/m2 * HbA1c value between 7.5% and 11%
Exclusion criteria
* Treated with oral anti-diabetic medications other than metformin and sulfonylurea within 3 months of screening * Patients treated previously with AC2993 * Patients presently treated with insulin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c from Baseline to Week 30 | Baseline (Day 1) to Week 30 | Change in HbA1c from Baseline (Day 1) to study termination (Week 30) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of subjects achieving HbA1c target values of < 7% and < 8% by Week 30 | Baseline (Day 1) and Week 30 | The number of subjects achieving HbA1c target values of \< 7% and \< 8% by study termination (Week 30) |
| The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by Week 30 | Baseline (Day 1), and Week 30 | The number of subjects achieving HbA1c reductions of \> 0.5% and \> 1.0% by study termination (Week 30) |
| Change in HbA1c from baseline (Day 1) to each of the intermediate visits | Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24 | Change in HbA1c from baseline, measured from Visit 3 (Day 1) to each of the intermediate visits (Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, and Week 24) |
| The time to achieve HbA1c reductions of 0.5% or more and >1.0% or more | Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30 | The time it takes subjects to achieve HbA1c reductions of 0.5% or more and \>1.0% or more |
| Change in body weight from Baseline to each intermediate visit and Week 30 | Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30 | Change in body weight (kg) from Baseline to each intermediate visit and Week 30 |
| The time to achieve specific HbA1c target values of < 7% and < 8% | Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30 | The time it takes subjects to achieve HbA1c target values of \< 7% and \< 8% |
Countries
United States
Outcome results
None listed