Diabetes Mellitus, Non-Insulin-Dependent
Conditions
Keywords
Diabetes Mellitus, Type 2
Brief summary
This is a multicenter, randomized, blinded, placebo-controlled, short-term, dose-response study to examine the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be individuals with type 2 diabetes treated with metformin for at least 3 months prior to screening. Patients whose diabetes management consists of diet and exercise will also be eligible for this study.
Interventions
DRUGPlacebo 0.01 mL
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.01 mL subcutaneously injected twice daily
DRUGPlacebo 0.02 mL
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.02 mL subcutaneously injected twice daily
DRUGPlacebo 0.03 mL
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.03 mL subcutaneously injected twice daily
DRUGPlacebo 0.04 mL
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.04 mL subcutaneously injected twice daily
DRUGAC2993 2.5 mcg
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 2.5 mcg (0.01 mL) subcutaneously injected twice daily
DRUGAC2993 5.0 mcg
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 5.0 mcg (0.02 mL) subcutaneously injected twice daily
DRUGAC2993 7.5 mcg
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 7.5 mcg (0.03 mL) subcutaneously injected twice daily
DRUGAC2993 10.0 mcg
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 10.0 mcg (0.04 mL) 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
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with type 2 diabetes * Treated with diet and exercise alone or with metformin for at least 3 months prior to screening * BMI 27-45 kg/m\^2 * HbA1c between 7.0 % and 8.0 %
Exclusion criteria
* Treated with other oral anti-diabetic agents other than metformin within 3 months of screening * Patients previously treated with AC2993 * Patients presently treated with insulin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28 | Baseline (Day 1) to Day 28 | Change in HbA1c from Baseline (Day 1) to study termination (Day 28) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c from Baseline to Day 14 | Baseline, Day 14 | Change in HbA1c from Baseline (Day 1) to Day 14 |
| Change in fasting plasma glucose from Baseline to Day 14 and to Day 28 | Baseline, Day 14, Day28 | Change in fasting plasma glucose from Baseline (Day 1) to Day 14 and to study termination (Day 28) |
| Change in serum fructosamine from Baseline (Day 1) to Day 14 and to Day 28 | Baseline, Day 14, Day 28 | Change in serum fructosamine from baseline (Day 1) to Visit 4 (Day 14) and to study termination (Day 28) |
Countries
United States
Outcome results
None listed