NCT01020123
Completed
Phase 2
A 4-month, Randomized, Double-blind, Placebo- and Active-Controlled, Multi-centre, Parallel-Group Study, With an Optional 2-month Extension, to Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus Patients
Overview
- Phase
- Phase 2
- Intervention
- AZD1656
- Conditions
- Type II Diabetes Mellitus
- Sponsor
- AstraZeneca
- Enrollment
- 530
- Locations
- 1
- Primary Endpoint
- HbA1c: Change From Baseline to 4 Month
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The primary aim is to evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in TD2M Patients
Investigators
Eligibility Criteria
Inclusion Criteria
- •female of non-childbearing potential
- •Treated with maximally tolerated dose of metformin (≥ 1500mg/day) for at least 10 weeks prior to enrolment.
- •Patients with HbA1c ≥ 7.5 but ≤ 10% at enrolment visit (Visit 1) can enter cohort 1.Patients with HbA1c between \>10 % and \<12 % can enter the open-label arm with AZD1656 (cohort 2)
Exclusion Criteria
- •Significant cardiovascular event within the last 6 months prior to enrolment or heart failure New York Heart Association (NYHA) class III-IV.
- •Impaired renal function in terms of GFR\<60 ml/min, based on Modification of Diet in Renal Disease Study Group (MDRD) calculation.
- •Use of warfarin or amiodarone within 3 months prior to enrolment (screening) and use of potent CYP450 inhibitors, eg, ketoconazole and/or macrolide antibiotics within 14 days before randomisation.
Arms & Interventions
1
AZD1656
Intervention: AZD1656
2
AZD1656
Intervention: AZD1656
3
AZD1656
Intervention: AZD1656
4
AZD1656
Intervention: AZD1656
5
AZD1656
Intervention: AZD1656
6
Intervention: Placebo
7
Glipizide administered to 1 group of patients
Intervention: Glipizide
Outcomes
Primary Outcomes
HbA1c: Change From Baseline to 4 Month
Time Frame: Baseline to 4th Month
AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue
Secondary Outcomes
- OGTT/Insulin(baseline to 4 month)
- FPG: to Evaluate Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.(baseline to 4 month)
- SMPG: Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.(baseline to 4 month)
- OGTT/Plasma Glucose(baseline to 4 month)
- OGTT/C-peptide(baseline to 4 month)
- OGTT/Pro-insulin/Insulin(baseline to 4 month)
- HbA1c ≤ 7(baseline to 4 month)
- HbA1c ≤ 6.5(baseline to 4 month)
- LDL-C: Mean Ratio(baseline to 4 month)
- HDL-C: Change From Baseline(baseline to 4 month)
- Total Cholesterol: Change From Baseline(baseline to 4 month)
- Triglycerides: Change From Baseline(baseline to 4 month)
- C-reactive Protein: Change From Baseline(baseline to 4 month)
- Systolic Blood Pressure, Change From Baseline(baseline to 4 month)
- Diastolic Blood Pressure, Change From Baseline(baseline to 4 month)
- Pulse, Change From Baseline(baseline to 4 month)
- Weight, Change From Baseline(baseline to 4 month)
- QTcF; Electorcardiagram Change From Baseline(baseline to 4 month)
- Haemoglobin; Change From Baseline(baseline to 4 month)
- Leukocytes; Change From Baseline(baseline to 4 month)
- Sodium; Change From Baseline(baseline to 4 month)
- Potassium; Change From Baseline(baseline to 4 month)
- Creatinine; Change From Baseline(baseline to 4 month)
- ALT; Change From Baseline(baseline to 4 month)
- AST; Change From Baseline(baseline to 4 month)
- Alkaline Phosphatase; Change From Baseline(baseline to 4 month)
- Bilirubin; Change From Baseline(baseline to 4 month)
- CL/F to Characterise the PK Properties of AZD1656.(at 4 month)
- EC50 to Characterise the PD Properties of AZD1656.(at 4 month)
Study Sites (1)
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