NCT02284893|CompletedPhase 3Results

Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

A 26-week International, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3bTrial With a Blinded 26-week Long -Term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

AstraZeneca ClinicalTrials.gov

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2 other identifiers

CV181-3632014-001102-17

Study Type

interventional

Target

461

Locations

6 countries

Sites

Timeline

RegisteredNov 2014

StartedSep 2014

CompletionSep 2016

Brief Summary

Study will evaluate if a combination of saxagliptin and dapagliflozin added concurrently to metformin in combination with diet and exercise is superior to sitagliptin added to metformin in combination with diet and exercise in reducing mean HbA1c over a treatment period of 26 weeks.

Trial Health

On Track

Trial Health Score

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

Enrollment

461

participants targeted

Target at P50-P75 for phase_3 type-2-diabetes

Timeline

Completed

Started Sep 2014

Typical duration for phase_3 type-2-diabetes

Geographic Reach

6 countries

79 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

2 years study duration

Study Start

First participant enrolled

September 9, 2014

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2014

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2014

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2016

Completed

1.7 years until next milestone

Results Posted

Study results publicly available

June 1, 2018

Completed

Last Updated

June 1, 2018

Status Verified

May 1, 2018

Enrollment Period

2 years

First QC Date

November 4, 2014

Results QC Date

September 18, 2017

Last Update Submit

May 29, 2018

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

Mean Change in HbA1c
Baseline (randomization) to Week 26

Secondary Outcomes (3)

Percent of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%
week 26
Mean Change in Total Body Weight
Baseline (randomization) to Week 26
Mean Change in Fasting Plasma Glucose (FPG)
Baseline (randomization) to Week 26

Study Arms (2)

A1:Saxagliptin / Placebo + Dapagliflozin / Placebo

EXPERIMENTAL

Saxagliptin 5 mg and matching placebo 0 mg (once daily) plus Dapagliflozin 10 mg and matching placebo 0 mg (once daily)

Drug: SaxagliptinDrug: DapagliflozinDrug: Placebo matching with SaxagliptinDrug: Placebo matching with Dapagliflozin

A2: Sitagliptin / placebo

EXPERIMENTAL

Sitagliptin 100 mg and matching placebo 0 mg (once daily)

Drug: SitagliptinDrug: Placebo matching with Sitagliptin