Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

Browse trials for

• Diabetes Mellitus 10,925
• Diabetes Mellitus, Type 2 9,359

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 908 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Study arms

• Experimental
  Efpeglenatide 4 mg

  Participants received Efpeglenatide subcutaneous (SC) injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 4 mg once weekly for the treatment duration.

  Drug: Efpeglenatide · Drug: Background therapy Metformin

• Experimental
  Efpeglenatide 6 mg

  Participants received Efpeglenatide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 2 mg once weekly and increased every 2 weeks to the maximum of 6 mg once weekly for the treatment duration.

  Drug: Efpeglenatide · Drug: Background therapy Metformin

• Active comparator
  Dulaglutide 1.5 mg

  Participants received Dulaglutide SC injection once weekly up to Week 56 on top of metformin. Participants initiated dosing at 0.75 mg once weekly and increased after 2 weeks to 1.5 mg once weekly for the treatment duration.

  Drug: Dulaglutide · Drug: Background therapy Metformin

Interventions

• DrugEfpeglenatide

  Pharmaceutical form: solution for injection; Route of administration: SC

  Also known as: SAR439977

• DrugDulaglutide

  Pharmaceutical form: solution for injection; Route of administration: SC

  Also known as: Trulicity™

• DrugBackground therapy Metformin

  Pharmaceutical form: tablet; Route of administration: oral; Dose to be kept stable throughout the study.

Primary outcomes

1. Change From Baseline to Week 56 in HbA1c

   Adjusted Least square (LS) means and Standard errors (SE) were obtained from analysis of covariance (ANCOVA) model to account for missing data. Missing values were imputed by baseline observation carried forward (BOCF)-like multiple imputation method.

   Time frame: Baseline to Week 56

Secondary outcomes

1. Change From Baseline to Week 56 in Body Weight

   Adjusted LS means and SE were obtained from ANCOVA model to account for missing data. Missing values were imputed by BOCF-like multiple imputation method.

   Time frame: Baseline to Week 56

2. Number of Participants With HbA1c < 7.0 %

   Participants who had no available assessment for HbA1c at Week 56 were considered as non-responders.

   Time frame: Week 56

3. Change From Baseline to Week 56 in Fasting Plasma Glucose (FPG)

   Adjusted LS means and SE were obtained from ANCOVA model to account for missing data. Missing values were imputed by BOCF-like multiple imputation method.

   Time frame: Baseline to Week 56

4. Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], Severe Hypoglycemia)

   Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<54 milligrams per deciliter (mg/dL) (\<3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.

   Time frame: Baseline up to Week 56

5. Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL] and Severe Hypoglycemia) Per Participant-Year

   Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<54 mg/dL (\<3.0 mmol/L). Severe hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.

   Time frame: Baseline up to Week 56

Baseline characteristics

Study documents

• Study protocol · Jul 31, 2019
• Statistical analysis plan · Oct 2, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — No plan to share individual participant data (IPD) by SANOFI: Product rights transferred to Hanmi Pharmaceutical.