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A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca, Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01095653
First received: March 26, 2010
Last updated: December 13, 2016
Last verified: December 2016
  Purpose
The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can improve (decrease) blood glucose values in Asian patients with Type 2 Diabetes who have never been treated with medication or have been on medication for less than 24 weeks since their original diagnosis of Diabetes. The safety of this treatment will also be studied.

Condition Intervention Phase
Type 2 Diabetes
Drug: Dapagliflozin
Drug: Metformin
Drug: Dapagliflozin Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Asian Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]) [ Time Frame: From Baseline to Week 24 ]
    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.


Secondary Outcome Measures:
  • Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF]) [ Time Frame: From Baseline to Week 24 ]
    Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. 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. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double-blind period.

  • Adjusted Mean Change From Baseline in 2-hour Post Liquid Meal Glucose (PLMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF]) [ Time Frame: From Baseline to Week 24 ]
    Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Post Liquid Meal Glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. 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. PLMG measurements were obtained on Day 1 and week 24 in the double-blind period.

  • Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF]) [ Time Frame: From Baseline to Week 24 ]
    Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. 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. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.

  • Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF]) [ Time Frame: From Baseline to Week 24 ]
    Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Mean and standard error for percentage of participants were estimated by modified logistic regression model.


Enrollment: 1179
Study Start Date: June 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Drug: Dapagliflozin
Tablets, Oral, 5 mg, Once daily, 24 weeks
Other Name: BMS-512148
Drug: Metformin
Tablets, Oral, 500-2000 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks
Other Name: Glucophage®
Drug: Dapagliflozin Placebo
Tablets, Oral, 0 mg, Once daily, 24 weeks
Experimental: Group 2 Drug: Dapagliflozin
Tablets, Oral, 10 mg, Once daily, 24 weeks
Other Name: BMS-512148
Drug: Metformin
Tablets, Oral, 500-2000 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks
Other Name: Glucophage®
Drug: Dapagliflozin Placebo
Tablets, Oral, 0 mg, Once daily, 24 weeks
Experimental: Group 3 Drug: Metformin
Tablets, Oral, 500-2000 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks
Other Name: Glucophage®
Drug: Dapagliflozin Placebo
Tablets, Oral, 0 mg, Once daily, 24 weeks

  Eligibility

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

Inclusion Criteria:

  • Males and females, 18 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01095653

  Hide Study Locations
Locations
China, Anhui
Local Institution
Hefei, Anhui, China, 230022
China, Beijing
Local Institution
Beijing, Beijing, China, 100029
Local Institution
Beijing, Beijing, China, 100044
Local Institution
Beijing, Beijing, China, 100730
Local Institution
Beijing, Beijing, China, 100853
China, Chongqing
Local Institution
Chongqing, Chongqing, China, 40016
China, Guangdong
Local Institution
Guanzhou, Guangdong, China, 510120
China, Hubei
Local Institution
Wuhan, Hubei, China, 430022
China, Hunan
Local Institution
Changsha, Hunan, China, 410000
Local Institution
Changsha, Hunan, China, 410008
China, Jiangsu
Local Institution
Nanjing, Jiangsu, China, 210008
Local Institution
Nanjing, Jiangsu, China, 210012
Local Institution
Wuxi, Jiangsu, China, 214023
China, Jilin
Local Institution
Changchun, Jilin, China, 130041
China, Liaoning
Local Institution
Shenyang, Liaoning, China, 110003
China, Shanghai
Local Institution
Shanghai, Shanghai, China, 200003
Local Institution
Shanghai, Shanghai, China, 200040
Local Institution
Shanghai, Shanghai, China, 200065
China, Sichuan
Local Institution
Chengdu, Sichuan, China, 610072
China, Tianjin
Local Institution
Tianjin, Tianjin, China, 300211
China, Zhejiang
Local Institution
Hangzhou, Zhejiang, China, 310003
Local Institution
Hangzhou, Zhejiang, China, 310009
China
Local Institution
Beijing, China, 100034
Local Institution
Wuhan, China, 430030
Local Institution
Xian, China, 710032
India
Local Institution
Bangalore, Karnataka, India, 560043
Local Institution
Indore, Madhya Pradesh, India, 452010
Local Institution
Bangalore, India, 560092
Local Institution
Jaipur, India, 302023
Korea, Republic of
Local Institution
Seoul, Nowon-GU, Korea, Republic of, 139-711
Local Institution
Busanjin-gu, Korea, Republic of, 633-165
Local Institution
Guri-si, Korea, Republic of, 471-701
Local Institution
Seoul, Korea, Republic of, 120-752
Local Institution
Seoul, Korea, Republic of, 137040
Taiwan
Local Institution
Taichung, Taiwan, 402
Local Institution
Taichung, Taiwan, 43303
Local Institution
Taipei, Taiwan, 110
Local Institution
Taipei, Taiwan, 235
Local Institution
Yung Kang city, Taiwan, 71044
Sponsors and Collaborators
AstraZeneca
AstraZeneca, Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01095653     History of Changes
Other Study ID Numbers: MB102-054
Study First Received: March 26, 2010
Results First Received: September 30, 2016
Last Updated: December 13, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2017