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OpenTrials
Completed

NCT Number: NCT01020123

Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus (TD2M) Patients

The primary aim is to evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in TD2M Patients

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Key information

Conditions

Type II Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Temuco, Araucania, Chile

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD1656

Drug

Different doses of AZD1656 administered to 5 groups of patients

Placebo

Drug

AZD1656 placebo and glipizide placebo administered to 1 group of patients

Glipizide

Drug

Glipizide administered to 1 group of patients

Primary outcomes

  1. 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

  1. FPG: to Evaluate Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.

    Time frame: baseline to 4 month

    AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue.

  2. SMPG: Change From Baseline to 4 Month, Compared With Placebo, FAS Prior to Rescue.

    Time frame: baseline to 4 month

    AZD1656 is analyzed in a ANCOVA model (Glipized and Open Label is Not Included in the model), FAS Prior to Rescue.

  3. OGTT/Plasma Glucose

    Time frame: baseline to 4 month

    The relative change in AUC

  4. OGTT/Insulin

    Time frame: baseline to 4 month

    The Relative Change in AUC FAS Prior to Rescue

  5. OGTT/C-peptide

    Time frame: baseline to 4 month

    The relative change, FAS prior to rescue

  6. OGTT/Pro-insulin/Insulin

    Time frame: baseline to 4 month

    The relative change, FAS prior to rescue

  7. HbA1c ≤ 7

    Time frame: baseline to 4 month

    Number of responders ≤ 7, FAS prior to rescue.

  8. HbA1c ≤ 6.5

    Time frame: baseline to 4 month

    Number of Responders ≤ 6.5, FAS Prior to Rescue

  9. LDL-C: Mean Ratio

    Time frame: baseline to 4 month

    Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.

  10. HDL-C: Change From Baseline

    Time frame: baseline to 4 month

    Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.

  11. Total Cholesterol: Change From Baseline

    Time frame: baseline to 4 month

    Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI.

  12. Triglycerides: Change From Baseline

    Time frame: baseline to 4 month

    Summary statistic of change from baseline

  13. C-reactive Protein: Change From Baseline

    Time frame: baseline to 4 month

    Geometric mean ratio (safety analysis set, regardless of rescue) and a 95 % CI

  14. Systolic Blood Pressure, Change From Baseline

    Time frame: baseline to 4 month

    Summary statistic of change from baseline

  15. Diastolic Blood Pressure, Change From Baseline

    Time frame: baseline to 4 month

    Summary statistic of change from baseline

  16. Pulse, Change From Baseline

    Time frame: baseline to 4 month

    Summary statistic of change from baseline

  17. Weight, Change From Baseline

    Time frame: baseline to 4 month

    Summary statistic of change from baseline

  18. QTcF; Electorcardiagram Change From Baseline

    Time frame: baseline to 4 month

    Summary statistic of change from baseline

  19. Haemoglobin; Change From Baseline

    Time frame: baseline to 4 month

    Summary statistic of change from baseline

  20. Leukocytes; Change From Baseline

    Time frame: baseline to 4 month

    Summary statistic of change from baseline

  21. Sodium; Change From Baseline

    Time frame: baseline to 4 month

    Summary statistic of change from baseline

  22. Potassium; Change From Baseline

    Time frame: baseline to 4 month

    Summary statistic of change from baseline

  23. Creatinine; Change From Baseline

    Time frame: baseline to 4 month

    Summary statistic of change from baseline

  24. ALT; Change From Baseline

    Time frame: baseline to 4 month

    Summary statistic of change from baseline

  25. AST; Change From Baseline

    Time frame: baseline to 4 month

    Summary statistic of change from baseline

  26. Alkaline Phosphatase; Change From Baseline

    Time frame: baseline to 4 month

    Summary statistic of change from baseline

  27. Bilirubin; Change From Baseline

    Time frame: baseline to 4 month

    Summary statistic of change from baseline

  28. CL/F to Characterise the PK Properties of AZD1656.

    Time frame: at 4 month

    The value is calculated using an allometric model (of a patient weighting 75 kg). The value is independent treatment given.

  29. EC50 to Characterise the PD Properties of AZD1656.

    Time frame: at 4 month

    The value is model based. The value is independent treatment given.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 25, 2009
Registry last updated
Nov 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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