Diabetes Mellitus, Type 2
Conditions
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 medication (metformin) 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 / Placebo (0.02 mL) for 4 weeks / Placebo (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 metformin within a defined dose range 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 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 (glycosylated hemoglobin) from baseline to study termination (Week 30) | Baseline (Day 1), Week 30 | Change in HbA1c from from baseline, measured from Visit 3 (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