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CompletedNCT01095653Updated Feb 6, 2017Results posted

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

A Phase 3 interventional study of Dapagliflozin and Dapagliflozin in Type 2 Diabetes, sponsored by AstraZeneca. Completed at 39 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-06.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,179
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Type 2 Diabetes
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 1,179 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.

Browse AstraZeneca studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,179 participants (actual)

Study arms

  • Experimental
    Group 1

    Drug: Dapagliflozin · Drug: Metformin · Drug: Dapagliflozin Placebo

  • Experimental
    Group 2

    Drug: Dapagliflozin · Drug: Metformin · Drug: Dapagliflozin Placebo

  • Experimental
    Group 3

    Drug: Metformin · Drug: Dapagliflozin Placebo

Interventions

  • DrugDapagliflozin

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

    Also known as: BMS-512148

  • DrugDapagliflozin

    Tablets, Oral, 10 mg, Once daily, 24 weeks

    Also known as: BMS-512148

  • DrugMetformin

    Tablets, Oral, 500-2000 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks

    Also known as: Glucophage®

  • DrugDapagliflozin Placebo

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

06

What researchers measure

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.

    Time frame: From Baseline to Week 24

Secondary outcomes

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

    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.

    Time frame: From Baseline to Week 24

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

    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.

    Time frame: From Baseline to Week 24

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

    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.

    Time frame: From Baseline to Week 24

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

    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.

    Time frame: From Baseline to Week 24

07

Results

Posted Feb 6, 2017

Participant flow

Of 1179 participants enrolled, 514 completed a qualification period. Of these 514 participants, 393 were randomized and received treatment. Of these 393 participants, 343 completed double-blind treatment period.

Participant flow — Overall Study
MilestonePlaceboDapagliflozin 5 mgDapagliflozin 10 mg
Started132128133
Completed113113117
Not completed191516
Withdrew: Lack of efficacy300
Withdrew: Adverse event144
Withdrew: Lost to follow-up104
Withdrew: Withdrawal by subject453
Withdrew: Non-compliance, not met criteria, etc.1065

Outcome measures

PrimaryAdjusted 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.

Time frame:
From Baseline to Week 24
Reported as:
Mean · % of hemoglobin
Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])
% of hemoglobinPlaceboDapagliflozin 5 mgDapagliflozin 10 mg
Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])-0.29 ± 0.0681-1.04 ± 0.0695-1.11 ± 0.0680
Statistical analysis
  • Placebo vs Dapagliflozin 5 mg · ANCOVA · p = <0.0001 (Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment) · Mean difference (final values): -0.75 · 95% CI -0.94 to -0.56
  • Placebo vs Dapagliflozin 10 mg · ANCOVA · p = <0.0001 (Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment) · Mean difference (final values): -0.82 · 95% CI -1.01 to -0.63
SecondaryAdjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])

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.

Time frame:
From Baseline to Week 24
Reported as:
Mean · mg/dL
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])
mg/dLPlaceboDapagliflozin 5 mgDapagliflozin 10 mg
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])2.5 ± 2.237-25.1 ± 2.274-31.6 ± 2.255
Statistical analysis
  • Placebo vs Dapagliflozin 5 mg · ANCOVA · p = <0.0001 (Secondary endpoints were tested following a sequential testing procedure at alpha=0.05) · Mean difference (final values): -27.7 · 95% CI -34.0 to -21.4
  • Placebo vs Dapagliflozin 10 mg · ANCOVA · p = <0.0001 (Secondary endpoints were tested following a sequential testing procedure at alpha=0.05) · Mean difference (final values): -34.2 · 95% CI -40.4 to -27.9
SecondaryAdjusted Mean Change From Baseline in 2-hour Post Liquid Meal Glucose (PLMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])

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.

Time frame:
From Baseline to Week 24
Reported as:
Mean · mg/dL
Adjusted Mean Change From Baseline in 2-hour Post Liquid Meal Glucose (PLMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])
mg/dLPlaceboDapagliflozin 5 mgDapagliflozin 10 mg
Adjusted Mean Change From Baseline in 2-hour Post Liquid Meal Glucose (PLMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])1.08 ± 4.5663-46.8 ± 4.6559-54.9 ± 4.5257
Statistical analysis
  • Placebo vs Dapagliflozin 5 mg · ANCOVA · p = <0.0001 (Secondary endpoints were tested following a sequential testing procedure at alpha=0.05) · Mean difference (final values): -47.9 · 95% CI -60.80 to -34.96
  • Placebo vs Dapagliflozin 10 mg · ANCOVA · p = <0.0001 (Secondary endpoints were tested following a sequential testing procedure at alpha=0.05) · Mean difference (final values): -56.0 · 95% CI -68.66 to -43.28
SecondaryAdjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])

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.

Time frame:
From Baseline to Week 24
Reported as:
Mean · kg
Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])
kgPlaceboDapagliflozin 5 mgDapagliflozin 10 mg
Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])-0.27 ± 0.2279-1.64 ± 0.2315-2.25 ± 0.2308
Statistical analysis
  • Placebo vs Dapagliflozin 5 mg · ANCOVA · p = <0.0001 (Secondary endpoints were tested following a sequential testing procedure at alpha=0.05) · Mean difference (final values): -1.37 · 95% CI -2.01 to -0.73
  • Placebo vs Dapagliflozin 10 mg · ANCOVA · p = <0.0001 (Secondary endpoints were tested following a sequential testing procedure at alpha=0.05) · Mean difference (final values): -1.98 · 95% CI -2.62 to -1.34
SecondaryPercentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])

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.

Time frame:
From Baseline to Week 24
Reported as:
Mean · Percentage of participants
Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
Percentage of participantsPlaceboDapagliflozin 5 mgDapagliflozin 10 mg
Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])21.3 ± 3.31042.6 ± 4.30049.8 ± 4.032
Statistical analysis
  • Placebo vs Dapagliflozin 5 mg · Modified logistic regression · p = <0.0001 (Secondary endpoints were tested following a sequential testing procedure at alpha=0.05) · Mean difference (final values): 21.3 · 95% CI 11.1 to 31.6
  • Placebo vs Dapagliflozin 10 mg · Modified logistic regression · p = <0.0001 (Secondary endpoints were tested following a sequential testing procedure at alpha=0.05) · Mean difference (final values): 28.5 · 95% CI 18.6 to 38.3

Adverse events

Collected over Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—2/132 (1.5%)38/132 (28.8%)
Dapagliflozin 5 mg—5/128 (3.9%)28/128 (21.9%)
Dapagliflozin 10 mg—4/133 (3%)23/133 (17.3%)
Most frequent serious events
Showing 10 of 11
Most frequent serious events
EventPlaceboDapagliflozin 5 mgDapagliflozin 10 mg
CEREBRAL INFARCTIONNervous system disorders0/1322/1280/133
GOITREEndocrine disorders0/1321/1281/133
CHOLECYSTITISHepatobiliary disorders0/1321/1280/133
ANKLE FRACTUREInjury, poisoning and procedural complications0/1321/1280/133
PANCREATIC CARCINOMANeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1321/1280/133
MYOCARDIAL INFARCTIONCardiac disorders1/1320/1280/133
CHOLECYSTITIS ACUTEHepatobiliary disorders1/1320/1280/133
PYLORIC STENOSISCongenital, familial and genetic disorders0/1320/1281/133
GASTRIC ULCERGastrointestinal disorders0/1320/1281/133
URETHRITISInfections and infestations0/1320/1281/133
Most frequent other events
Most frequent other events
EventPlaceboDapagliflozin 5 mgDapagliflozin 10 mg
HYPERLIPIDAEMIAMetabolism and nutrition disorders14/13210/1289/133
UPPER RESPIRATORY TRACT INFECTIONInfections and infestations12/13210/1289/133
NASOPHARYNGITISInfections and infestations5/1327/1284/133
DYSLIPIDAEMIAMetabolism and nutrition disorders7/1323/1282/133

Baseline characteristics

All randomized participants who received at least 1 dose of study medication

Age, Continuous
Age, Continuous(Years)PlaceboDapagliflozin 5 mgDapagliflozin 10 mgTotal
Mean49.9 ± 10.8753.0 ± 11.0751.2 ± 9.8951.3 ± 10.67
Age, Customized
Age, Customized(Participants)PlaceboDapagliflozin 5 mgDapagliflozin 10 mgTotal
Younger than 65 years120108123351
65 to younger than 75 years11141035
75 years and older1607
Sex/Gender, Customized
Sex/Gender, Customized(Participants)PlaceboDapagliflozin 5 mgDapagliflozin 10 mgTotal
Male878486257
Female454447136
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PlaceboDapagliflozin 5 mgDapagliflozin 10 mgTotal
ASIAN INDIAN88925
CHINESE117114117348
JAPANESE1012
KOREAN56516
ASIAN OTHER1012
Weight
Weight(kg)PlaceboDapagliflozin 5 mgDapagliflozin 10 mgTotal
Mean72.18 ± 13.23468.89 ± 11.42970.92 ± 11.63770.68 ± 12.177
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)PlaceboDapagliflozin 5 mgDapagliflozin 10 mgTotal
Mean25.93 ± 3.64425.17 ± 3.28525.76 ± 3.43425.62 ± 3.465
08

Study locations

39 sites
  • Local Institution
    Hefei, Anhui 230022, China
  • Local Institution
    Beijing, Beijing Municipality 100029, China
  • Local Institution
    Beijing, Beijing Municipality 100044, China
  • Local Institution
    Beijing, Beijing Municipality 100730, China
  • Local Institution
    Beijing, Beijing Municipality 100853, China
  • Local Institution
    Chongqing, Chongqing Municipality 40016, China
  • Local Institution
    Guanzhou, Guangdong 510120, China
  • Local Institution
    Wuhan, Hubei 430022, China
  • Local Institution
    Changsha, Hunan 410000, China
  • Local Institution
    Changsha, Hunan 410008, China
  • Local Institution
    Nanjing, Jiangsu 210008, China
  • Local Institution
    Nanjing, Jiangsu 210012, China
  • Local Institution
    Wuxi, Jiangsu 214023, China
  • Local Institution
    Changchun, Jilin 130041, China
  • Local Institution
    Shenyang, Liaoning 110003, China
  • Local Institution
    Shanghai, Shanghai Municipality 200003, China
  • Local Institution
    Shanghai, Shanghai Municipality 200040, China
  • Local Institution
    Shanghai, Shanghai Municipality 200065, China
  • Local Institution
    Chengdu, Sichuan 610072, China
  • Local Institution
    Tianjin, Tianjin Municipality 300211, China
  • Local Institution
    Hangzhou, Zhejiang 310003, China
  • Local Institution
    Hangzhou, Zhejiang 310009, China
  • Local Institution
    Beijing, 100034, China
  • Local Institution
    Wuhan, 430030, China
  • Local Institution
    Xi'an, 710032, China
  • Local Institution
    Bangalore, Karnataka 560043, India
  • Local Institution
    Indore, Madhya Pradesh 452010, India
  • Local Institution
    Bangalore, 560092, India
  • Local Institution
    Jaipur, 302023, India
  • Local Institution
    Seoul, Nowon-GU 139-711, South Korea
  • Local Institution
    Busanjin-gu, 633-165, South Korea
  • Local Institution
    Guri-si, 471-701, South Korea
  • Local Institution
    Seoul, 120-752, South Korea
  • Local Institution
    Seoul, 137040, South Korea
  • Local Institution
    Taichung, 402, Taiwan
  • Local Institution
    Taichung, 43303, Taiwan
  • Local Institution
    Taipei, 110, Taiwan
  • Local Institution
    Taipei, 235, Taiwan
  • Local Institution
    Yung Kang City, 71044, Taiwan
09

References and documents

Related links

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01095653
Lead sponsor
AstraZeneca
Collaborators
Astra Zeneca, Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Mar 30, 2010
Start date
Jun 2010
Primary completion
Mar 2012
Completion
Mar 2012
Results posted
Feb 6, 2017
Last update
Feb 6, 2017

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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