A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

NCT01095666 | Completed Phase 3 Results DMC

• 1 other identifier: MB102-055
• Study Type: interventional
• Target: 1,484
• Locations: 3 countries
• Sites: 33

Brief Summary

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in Asian patients with Type 2 Diabetes who are not well controlled on metformin alone. The safety of this treatment will also be studied.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])

  HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.

  From Baseline to Week 24

Secondary Outcomes (4)

• Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])

  From Baseline to Week 24

• Adjusted Mean Change From Baseline in 2-hour Post Meal Glucose (PMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])

  From Baseline to Week 24

• Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])

  From Baseline to Week 24

• Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])

  From Baseline to Week 24

Study Arms (3)

Group 1

EXPERIMENTAL

Drug: Dapagliflozin; Drug: Metformin; Drug: Dapagliflozin Placebo; Drug: Pioglitazone

Group 2

EXPERIMENTAL

Drug: Dapagliflozin; Drug: Metformin; Drug: Dapagliflozin Placebo; Drug: Pioglitazone

Group 3

EXPERIMENTAL

Drug: Metformin; Drug: Dapagliflozin Placebo; Drug: Pioglitazone

Interventions

Dapagliflozin DRUG

Tablets, Oral, 5 mg, Once daily, 24 weeks

Also known as: BMS-512148

Group 1

Metformin DRUG

Tablets, Oral, 1500-3000 mg, Twice daily, 24 weeks

Also known as: Glucophage®

Group 1; Group 2; Group 3

Dapagliflozin Placebo DRUG

Tablets, Oral, 0 mg, Once daily, 24 weeks

Group 1; Group 2; Group 3

Pioglitazone DRUG

Tablets, Oral, 15-45 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, 18 to 77 years old, with type 2 diabetes and with inadequate glycemic control
• Drug naive or treated with anti-diabetic medication for \< 24 weeks
• C-peptide ≥ 1.0 ng/mL
• Body Mass Index ≤ 45.0 kg/m²

You may not qualify if:

• AST and/or ALT \> 3 times ULN
• Serum total bilirubin \> 2 mg/dL
• Serum creatinine ≥ 1.50 mg/dL for men or ≥ 1.40 mg/dL for women
• Creatine kinase ≥ 3 times ULN
• Symptoms of severely uncontrolled diabetes
• Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

Sponsors & Collaborators

• AstraZeneca: lead
• AstraZeneca, Bristol-Myers Squibb: collaborator

Study Sites (33)

Local Institution

Hefei, Anhui, 230022, China

Location

Local Institution

Beijing, Beijing Municipality, 100001, China

Location

Local Institution

Beijing, Beijing Municipality, 100029, China

Location

Local Institution

Beijing, Beijing Municipality, 100044, China

Location

Local Institution

Beijing, Beijing Municipality, 100700, China

Location

Local Institution

Beijing, Beijing Municipality, 100730, China

Location

Local Institution

Chongqing, Chongqing Municipality, 400016, China

Location

Local Institution

Guangzhou, Guangdong, 510120, China

Location

Local Institution

Haerbin, Heilongjiang, 150001, China

Location

Local Institution

Changsha, Hunan, 410000, China

Location

Local Institution

Changsha, Hunan, 410008, China

Location

Local Institution

Nanjing, Jiangsu, 210006, China

Location

Local Institution

Nanjing, Jiangsu, 210008, China

Location

Local Institution

Wuxi, Jiangsu, 214023, China

Location

Local Institution

Changchun, Jilin, 130041, China

Location

Local Institution

Shenyang, Liaoning, 110003, China

Location

Local Institution

Shanghai, Shanghai Municipality, 200003, China

Location

Local Institution

Shanghai, Shanghai Municipality, 200040, China

Location

Local Institution

Shanghai, Shanghai Municipality, 200065, China

Location

Local Institution

Chengdu, Sichuan, 610070, China

Location

Local Institution

Chongqing, Sichuan, 400010, China

Location

Local Institution

Tianjin, Tianjin Municipality, 300211, China

Location

Local Institution

Hangzhou, Zhejiang, 310009, China

Location

Local Institution

Xi'an, 710032, China

Location

Local Institution

Bangalore, Karnataka, 560 043, India

Location

Local Institution

Indore, Madhya Pradesh, 452010, India

Location

Local Institution

Bangalore, 560092, India

Location

Local Institution

Jaipur, 302023, India

Location

Local Institution

Vellore, Tamilnadu, 632004, India

Location

Local Institution

Seoul, Nowon-Gu, 139-711, South Korea

Location

Local Institution

Busan, 614-735, South Korea

Location

Local Institution

Seoul, 120-752, South Korea

Location

Local Institution

Seoul, 137-040, South Korea

Location

Related Links

• Publication

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin; Metformin; Pioglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Anna Maria Langkilde
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2010
• First Posted: March 30, 2010
• Study Start: June 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: September 11, 2017
• Results First Posted: September 11, 2017

Record last verified: 2017-09

Locations

KR (4); CN (24); IN (5)