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Completed

NCT Number: NCT03495102

A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes

The purpose of this study is to evaluate the efficacy and safety of investigational doses of once weekly dulaglutide when added to metformin in participants with type 2 diabetes with inadequate blood sugar control.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CEDIC-Centro de Investigaciones Clinicas, Caba, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have type 2 diabetes mellitus (T2DM) for at least 6 months
  • Have been treated with stable metformin dose for at least 3 months
  • Have HbA1c ≥7.5% and ≤11.0% at study entry
  • Have body mass index (BMI) ≥25 kilograms per meter squared (kg/m^2)

Exclusion criteria

  • Have type 1 diabetes mellitus
  • Have used any glucagon-like peptide-1 receptor agonist (GLP-1 RA) or insulin, not including prior short term insulin use (≤14 days)
  • Have been taking any other medicine for diabetes (other than metformin) during the last 3 months
  • Have used in the last 3 months (or plan to use) prescription weight loss medications
  • Have disorders associated with slowed emptying of the stomach contents, or have had any stomach surgeries for the purpose of weight loss
  • Current participation in or intent to begin during the study an organized diet and/or exercise weight reduction program (other than the lifestyle and dietary measures for diabetes)
  • Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine transaminase (ALT) level >2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial
  • Had chronic or acute pancreatitis any time prior to study entry
  • Have had a heart attack or stroke in the past 2 months, or have heart failure that significantly limits their physical activity
  • Estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73m^2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by the central laboratory at study entry and confirmed at lead-in
  • Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
  • Have proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator

Treatment and study plan

Dulaglutide

Drug

Administered SC

Other names: LY2189265

Primary outcomes

  1. Change in Hemoglobin A1c (HbA1c) From Baseline

    Time frame: Baseline, Week 36

    HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables:Baseline + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares).

Secondary outcomes

  1. Change in Body Weight From Baseline

    Time frame: Baseline, Week 36

    Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with independent variables: Baseline + Baseline HbA1c group + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares).

  2. Percentage of Participants Achieving HbA1c Target <7.0%

    Time frame: Week 36

    Percentage of participants achieving HbA1c target <7.0%.

  3. Change in Fasting Serum Glucose (FSG) From Baseline

    Time frame: Baseline, Week 36

    Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Baseline HbA1c group + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares).

  4. Rate of Documented Symptomatic Hypoglycemic Episodes

    Time frame: Week 36

    Hypoglycemia was defined as blood glucose < 54 mg/dL, excluding post-rescue records. Estimate is based on Group Mean from negative binomial model. The negative binomial model for post-baseline comparisons between treatments and control group: Number of episodes = Pooled Country + HbA1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.

  5. Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss)

    Time frame: Week 4, Week 12, Week 36, Week 52

    Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss).

  6. Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State

    Time frame: Week 4, Week 12, Week 36, Week 52

    Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Randomized, Double-Blind, Parallel Arm Study of the Efficacy and Safety of Investigational Dulaglutide Doses When Added to Metformin in Patients With Type 2 Diabetes Mellitus

Acronym: AWARD-11

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 11, 2018
Registry last updated
Jun 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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