NCT02096705

Brief Summary

The purpose is to determine if after 24 weeks of oral daily administration, there will be a greater mean reduction from baseline in glycosylated hemoglobin (HbA1c) achieved with Dapagliflozin 10 mg plus insulin compared to placebo plus insulin in subjects with type 2 diabetes.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
477

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline
Completed

Started Mar 2014

Typical duration for phase_3 diabetes

Geographic Reach
3 countries

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
5 days until next milestone

Study Start

First participant enrolled

March 31, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 6, 2017

Completed
Last Updated

August 9, 2017

Status Verified

July 1, 2017

Enrollment Period

1.8 years

First QC Date

March 24, 2014

Results QC Date

January 13, 2017

Last Update Submit

July 11, 2017

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Adjusted Mean Change in HbA1c From Baseline to Week 24

    The adjusted mean change in the percentage of Hemoglobin A1c (HbA1c) from baseline to Week 24 was reported for each arm.

    Baseline (Day 1) and 24 weeks

Secondary Outcomes (3)

  • Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24

    Baseline (Day 1) and 24 weeks

  • Adjusted Mean Change in Body Weight From Baseline to Week 24

    Baseline (Day 1) and 24 weeks

  • Adjusted Mean Change in Absolute Calculated Mean Total Daily Dose of Insulin (TDDI) From Baseline to Week 24

    Baseline (Day 1) and 24 weeks

Study Arms (2)

Group 1: Dapagliflozin

EXPERIMENTAL

Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin

Drug: Dapagliflozin

Group 2: Dapagliflozin Placebo

PLACEBO COMPARATOR

Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin

Drug: Dapagliflozin Placebo

Interventions

DapagliflozinDRUG

Tablet

Also known as: BMS-512148
Group 1: Dapagliflozin
Dapagliflozin PlaceboDRUG

Tablet

Group 2: Dapagliflozin Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must have type 2 diabetes with inadequate glycemic control, defined as HbA1c ≥ 7.5% and ≤ 11.0% obtained at screening visit
  • Subjects must be taking a stable mean dose of ≥ 20 IU injectable insulin daily for at least 8 weeks prior to enrollment
  • HbA1c ≥ 7.5 and ≤ 10.5% at Day -14

You may not qualify if:

  • Treatment with more than two oral antidiabetic (OAD) agents within 6 weeks of Enrollment
  • History of diabetic ketoacidosis of hyperosmolar nonketotic coma
  • Clinically diagnosed Type 1 diabetes mellitus
  • Congestive heart failure defined as New York Heart Association (NYHA) stage III and IV
  • Severe uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 180 mmHg and/or diastolic blood pressure (DBP) ≥ 110 mmHg
  • History of unstable or rapidly progressing renal disease
  • History of severe hepatobiliary disease
  • Mallingancy within 5 years of the screening/enrollment visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Local Institution

Beijing, Beijing Municipality, 100029, China

Location

Local Institution

Beijing, Beijing Municipality, 100700, China

Location

Local Institution

Beijing, Beijing Municipality, 100730, China

Location

Local Institution

Guangzhou, Guangdong, 510080, 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, 210012, China

Location

Local Institution

Suzhou, Jiangsu, 215004, China

Location

Local Institution

Wuxi, Jiangsu, 214023, China

Location

Local Institution

Changchun, Jilin, 130041, China

Location

Local Institution

Shanghai, Shanghai Municipality, 200040, China

Location

Local Institution

Shanghai, Shanghai Municipality, 200072, China

Location

Local Institution

Shanghai, Shanghai Municipality, 200080, China

Location

Local Institution

Shanghai, Shanghai Municipality, 200092, China

Location

Local Institution

Xi’an, Shanxi, 710032, China

Location

Local Institution

Xi’an, Shanxi, 710061, China

Location

Local Institution

Chengdu, Sichuan, 610072, China

Location

Local Institution

Chongqing, Sichuan, 400010, China

Location

Local Institution

Beijing, 100039, China

Location

Local Institution

Tianjin, China

Location

Local Institution

Singapore, 169856, Singapore

Location

Local Institution

Singapore, 529889, Singapore

Location

Local Institution

Busan, 49241, South Korea

Location

Local Institution

Daegu, 42415, South Korea

Location

Local Institution

Daejeon, 35233, South Korea

Location

Local Institution

Seoul, 06351, South Korea

Location

Local Institution

Seoul, 134-727, South Korea

Location

Related Publications (1)

  • Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

    PMID: 38770818DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Anna Maria Langkilde
Organization
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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 24, 2014

First Posted

March 26, 2014

Study Start

March 31, 2014

Primary Completion

January 28, 2016

Study Completion

January 28, 2016

Last Updated

August 9, 2017

Results First Posted

March 6, 2017

Record last verified: 2017-07

Locations

CN(22)SG(2)KR(5)