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Completed

NCT Number: NCT00575588

52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sulphonylurea in addition with metformin.

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Key information

Conditions

Type 2 Diabetes 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 3

Primary location

Research Site, Hanko, Finland

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with type 2 diabetes,
  • Treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks prior to Visit 1,
  • HbA1c >6.5% and ≤10.0%

Exclusion criteria

  • Type 1 diabetes,
  • history of diabetic ketoacidosis or hyperosmolar non-ketonic coma,
  • Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)

Treatment and study plan

metformin

Drug

open-label metformin

Sulphonylurea

Drug

Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks)

Saxagliptin

Drug

Saxagliptin 5 mg tablets

Other names: Onglyza

Primary outcomes

  1. Hemoglobin A1c (HbA1c) Change From Baseline to Week 52

    Time frame: Baseline to 52 Weeks

    Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 52 value minus the baseline value.

Secondary outcomes

  1. Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks

    Time frame: From Baseline to Week 52

    Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 52 weeks (Safety Analysis Set)

  2. Body Weight Change From Baseline to Week 52

    Time frame: Baseline, Week 52 (Last Observation Carried Forward)

    Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Safety Analysis Set). Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 52 (LOCF) value minus the baseline value.

  3. Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c

    Time frame: Week 24 to Week 52

    Mean slopes of regression of change from Week 24 to Week 52 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Per Protocol Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect.

Other outcomes

  1. Hemoglobin A1c (HbA1c) Change From Baseline to Week 104

    Time frame: Baseline, Week 104

    Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value.

  2. Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 104 Weeks

    Time frame: Baseline, Week 104

    Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 104 weeks (Safety Analysis Set)

  3. Body Weight Change From Baseline to Week 104

    Time frame: Baseline, Week 104

    Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104. Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value.

  4. Mean Slope of the Regressions of Change From Week 24 to Week 104 in HbA1c

    Time frame: Week 24 to Week 104

    Mean slopes of regression of change from Week 24 to Week 104 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Full Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

A 52-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 52-Week Extension Period to Evaluate the Safety and Efficacy of Saxagliptin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone.

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Dec 18, 2007
Registry last updated
Mar 21, 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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