Phase 2
Completed N=530
Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus (TD2M) Patients
Type II Diabetes Mellitus
Source: ClinicalTrials.gov NCT01020123 ↗
Enrolled (actual)
530
Serious AEs
2.1%
Results posted
Nov 2012
Primary outcomePrimary: HbA1c: Change From Baseline to 4 Month — -1.25; -1.26; -0.67; -0.61 Percentage
Summary
The primary aim is to evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in TD2M Patients
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c: Change From Baseline to 4 Month |
-1.25; -1.26; -0.67; -0.61; -0.45 | — |
| SECONDARY FPG: to Evaluate Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue. |
-0.818; -1.08; 0.041; 0.024; -0.182 | — |
| SECONDARY SMPG: Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue. |
-1.596; -1.557; -0.874; -0.604; -0.213 | — |
| SECONDARY OGTT/Plasma Glucose |
0.92; 0.84; 1.02; 0.99; 0.99 | — |
| SECONDARY OGTT/Insulin |
0.81; 1.08; 0.97; 0.90; 0.91 | — |
| SECONDARY OGTT/C-peptide |
0.97; 1.11; 0.90; 0.95; 1.00 | — |
| SECONDARY OGTT/Pro-insulin/Insulin |
1.496; 1.199; 1.248; 1.431; 1.185 | — |
| SECONDARY HbA1c ≤ 7 |
43; 43; 14; 11; 16; 50 | — |
| SECONDARY HbA1c ≤ 6.5 |
35; 27; 9; 4; 9; 30 | — |
| SECONDARY LDL-C: Mean Ratio |
1.07; 1.02; 1.07; 1.04; 1.02 | — |
| SECONDARY HDL-C: Change From Baseline |
1.06; 1.06; 1.05; 1.03; 1.03 | — |
| SECONDARY Total Cholesterol: Change From Baseline |
1.09; 1.08; 1.07; 1.04; 1.03 | — |
| SECONDARY Triglycerides: Change From Baseline |
40.9; 38.7; 19.8; 4.4; 13.7; 18.7 | — |
| SECONDARY C-reactive Protein: Change From Baseline |
0.30; 0.08; 0.09; 0.06; -0.02 | — |
| SECONDARY Systolic Blood Pressure, Change From Baseline |
-0.4; 0.4; 5.7; 0.1; -0.2; -1.1 | — |
| SECONDARY Diastolic Blood Pressure, Change From Baseline |
1.1; 1.4; 1.3; -0.9; -0.3; -0.1 | — |
| SECONDARY Pulse, Change From Baseline |
0.4; 1.6; 1.3; 0.3; -1.1; -0.4 | — |
| SECONDARY Weight, Change From Baseline |
-0.3; -0.6; -1.2; -1.4; -1.0; 1.0 | — |
| SECONDARY QTcF; Electorcardiagram Change From Baseline |
4.4; 4.0; -2.6; 3.8; 2.2; 2.7 | — |
| SECONDARY Haemoglobin; Change From Baseline |
-0.20; -0.18; 0.00; -0.11; -0.20; 0.02 | — |
| SECONDARY Leukocytes; Change From Baseline |
0.39; 0.34; 0.35; -0.15; -0.8; 0.27 | — |
| SECONDARY Sodium; Change From Baseline |
-0.6; -0.7; -0.4; -0.1; 0.0; -0.6 | — |
| SECONDARY Potassium; Change From Baseline |
0.02; -0.02; 0.00; -0.01; -0.02; 0.07 | — |
| SECONDARY Creatinine; Change From Baseline |
0.4; -9.9; 8.5; -8.3; -0.1; 15.9 | — |
| SECONDARY ALT; Change From Baseline |
2.0; 1.7; 3.2; -1.8; -0.4; 2.0 | — |
| SECONDARY AST; Change From Baseline |
2.4; 2.0; 2.8; -0.6; -0.1; 2.1 | — |
| SECONDARY Alkaline Phosphatase; Change From Baseline |
3.8; -1.3; 0.0; -1.8; -3.4; -4.2 | — |
| SECONDARY Bilirubin; Change From Baseline |
-0.02; -0.06; 0.02; -0.05; -0.01; -0.07 | — |
| SECONDARY CL/F to Characterise the PK Properties of AZD1656. |
9.29; 9.29; 9.29; 9.29; 9.29 | — |
| SECONDARY EC50 to Characterise the PD Properties of AZD1656. |
60.2; 60.2; 60.1; 60.2; 60.2 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01020123). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.