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

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ClinicalTrials.gov Identifier: NCT01020123
Recruitment Status : Completed
First Posted : November 25, 2009
Results First Posted : November 26, 2012
Last Update Posted : November 26, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Type II Diabetes Mellitus Drug: AZD1656 Drug: Placebo Drug: Glipizide Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 530 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : October 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
AZD1656
Drug: AZD1656
Different doses of AZD1656 administered to 5 groups of patients

Experimental: 2
AZD1656
Drug: AZD1656
Different doses of AZD1656 administered to 5 groups of patients

Experimental: 3
AZD1656
Drug: AZD1656
Different doses of AZD1656 administered to 5 groups of patients

Experimental: 4
AZD1656
Drug: AZD1656
Different doses of AZD1656 administered to 5 groups of patients

Experimental: 5
AZD1656
Drug: AZD1656
Different doses of AZD1656 administered to 5 groups of patients

Placebo Comparator: 6 Drug: Placebo
AZD1656 placebo and glipizide placebo administered to 1 group of patients

Active Comparator: 7
Glipizide administered to 1 group of patients
Drug: Glipizide
Glipizide administered to 1 group of patients




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01020123


  Show 76 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Eva Johnsson AstraZeneca R&D Mölndal
Principal Investigator: John Wilding, DM FRCP University Hospital Aintree

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01020123     History of Changes
Other Study ID Numbers: D1020C00009
First Posted: November 25, 2009    Key Record Dates
Results First Posted: November 26, 2012
Last Update Posted: November 26, 2012
Last Verified: November 2012

Keywords provided by AstraZeneca:
Type II Diabetes Mellitus
metformin
glipizide

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Glipizide
Hypoglycemic Agents
Physiological Effects of Drugs