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Completed

NCT Number: NCT00855166

Evaluation of the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 Diabetes

This study is being carried out to see if dapagliflozin in addition to metformin decreases body weight and if so, how it compares with metformin alone.

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Key information

Conditions

Type 2 Diabetes Mellitus Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Blagoevgrad, Bulgaria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes
  • Ongoing treatment with metformin on a stable dose of ≥1500 mg/day for at least 12 weeks prior to enrolment
  • Inadequate glycemic control, defined as HbA1c ≥6.5% and ≤8.5%
  • ≥30 years for males
  • ≥55 years for females

Exclusion criteria

  • Type 1 Diabetes
  • Body weight change >5% within 3 months prior to enrolment
  • Renal and liver impairment

Treatment and study plan

Dapagliflozin

Drug

Tablet oral 10 mg total daily dose once daily 102 weeks

metformin

Drug

Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks

Sitagliptin

Drug

Tablet oral 100 mg total daily dose once daily rescue medication

Placebo

Drug

Matching placebo for dapagliflozin, tablet, oral, once daily, 102 weeks

Primary outcomes

  1. Adjusted Mean Change in Total Body Weight

    Time frame: Baseline to Week 24

    To evaluate the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin on total body weight after 24 weeks of oral administration of double-blind treatment.

Secondary outcomes

  1. Adjusted Mean Change in Waist Circumference

    Time frame: Baseline to Week 24

    To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on waist circumference.

  2. Adjusted Mean Change in Body Fat Mass

    Time frame: Baseline to Week 24

    To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on total body fat mass measured by dual energy X-ray absorptiometry.

  3. Proportion of Participants With Body Weight Decrease ≥5%

    Time frame: Baseline to Week 24

    To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on body weight decrease ≥5%. Least Squares Mean represents the percent of participants adjusted for body weight baseline value.

Other outcomes

  1. Adjusted Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-4)

    Time frame: Baseline to Week 102

    To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at lumbar spine (L1-4) as measured by Dual Energy X-ray Absorptiometry.

  2. Adjusted Percent Change in Bone Mineral Density (BMD) at Femoral Neck

    Time frame: Baseline to Week 102

    To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at femoral neck as measured by Dual Energy X-ray Absorptiometry.

  3. Adjusted Percent Change in Bone Mineral Density (BMD) at Total Hip

    Time frame: Baseline to Week 102

    To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at total hip as measured by Dual Energy X-ray Absorptiometry.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

A 24-week,Multi-centre,Int.,Double-blind,Rand.,Parallel-group,Plac.-Controlled,Phase III Study With a 78-week Ext.Per. to Evaluate the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Mar 4, 2009
Registry last updated
Oct 14, 2013

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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