A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron and Dapagliflozin in Combination, Compared with Elecoglipron Alone and Dapagliflozin Alone, in Adults with Type 2 Diabetes Mellitus (Eluminate-5)

Conditions

type 2 diabetes mellitus

Brief summary

Change from baseline to Week 40 in HbA1c (%)

Detailed description

Change from baseline to Week 40 in HbA1c (%), Achieved HbA1c < 7% (53 mmol/mol) at Week 40 - Percent change from baseline to Week 40 in body weight - Change from baseline to Week 40 in body weight (kg), Change from baseline to Week 40 in HbA1c (%) - Percent change from baseline to Week 40 in body weight, Change from baseline to Week 40 in HbA1c (%) - Achieved HbA1c < 7% (53 mmol/mol) at Week 40 - Percent change from baseline to Week 40 in body weight - Change from baseline to Week 40 in body weight (kg), Change from baseline to Week 40 in FPG - Change from baseline to Week 40 in daily mean 7-point SMBG - Achieved ≥ 5% weight loss from baseline at Week 40 - Change from baseline to Week 40 in SBP and DBP - Time to initiation of rescue medication over 40 weeks, Change from baseline to Week 40 in FPG - Change from baseline to Week 40 in daily mean 7-point SMBG - Achieved ≥ 5% weight loss from baseline at Week 40 - Change from baseline to Week 40 in SBP and DBP - Time to initiation of rescue medication over 40 weeks, Change from baseline to Week 40 in FPG - Change from baseline to Week 40 in daily mean 7-point SMBG - Achieved ≥ 5% weight loss from baseline at Week 40 - Change from baseline to Week 40 in SBP and DBP - Time to initiation of rescue medication over 40 weeks

Related papers

No related papers found yet.

Interventions

DRUGElecoglipron

DRUGPlacebo for Elecoglipron (AZD5004)

DRUGForxiga 10 mg film-coated tablets

DRUGPlacebo for Forxiga

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline to Week 40 in HbA1c (%)	—

Secondary

Measure	Time frame
Change from baseline to Week 40 in HbA1c (%), Achieved HbA1c < 7% (53 mmol/mol) at Week 40 - Percent change from baseline to Week 40 in body weight - Change from baseline to Week 40 in body weight (kg), Change from baseline to Week 40 in HbA1c (%) - Percent change from baseline to Week 40 in body weight, Change from baseline to Week 40 in HbA1c (%) - Achieved HbA1c < 7% (53 mmol/mol) at Week 40 - Percent change from baseline to Week 40 in body weight - Change from baseline to Week 40 in body weight (kg), Change from baseline to Week 40 in FPG - Change from baseline to Week 40 in daily mean 7-point SMBG - Achieved ≥ 5% weight loss from baseline at Week 40 - Change from baseline to Week 40 in SBP and DBP - Time to initiation of rescue medication over 40 weeks, Change from baseline to Week 40 in FPG - Change from baseline to Week 40 in daily mean 7-point SMBG - Achieved ≥ 5% weight loss from baseline at Week 40 - Change from baseline to Week 40 in SBP and DBP - Time to initiation	—

Measure

Time frame

Change from baseline to Week 40 in HbA1c (%), Achieved HbA1c < 7% (53 mmol/mol) at Week 40 - Percent change from baseline to Week 40 in body weight - Change from baseline to Week 40 in body weight (kg), Change from baseline to Week 40 in HbA1c (%) - Percent change from baseline to Week 40 in body weight, Change from baseline to Week 40 in HbA1c (%) - Achieved HbA1c < 7% (53 mmol/mol) at Week 40 - Percent change from baseline to Week 40 in body weight - Change from baseline to Week 40 in body weight (kg), Change from baseline to Week 40 in FPG - Change from baseline to Week 40 in daily mean 7-point SMBG - Achieved ≥ 5% weight loss from baseline at Week 40 - Change from baseline to Week 40 in SBP and DBP - Time to initiation of rescue medication over 40 weeks, Change from baseline to Week 40 in FPG - Change from baseline to Week 40 in daily mean 7-point SMBG - Achieved ≥ 5% weight loss from baseline at Week 40 - Change from baseline to Week 40 in SBP and DBP - Time to initiation

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Outcome results

None listed