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A Study of Investigational Dulaglutide Doses in Participants With Type 2 Diabetes on Metformin Monotherapy

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ClinicalTrials.gov Identifier: NCT02973100
Recruitment Status : Completed
First Posted : November 25, 2016
Results First Posted : August 24, 2018
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of investigational doses of dulaglutide in participants with type 2 diabetes on metformin monotherapy.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Dulaglutide Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 318 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-Blind, Placebo-Controlled, 18-Week Trial of Investigational Dulaglutide Doses Versus Placebo in Patients With Type 2 Diabetes on Metformin Monotherapy
Study Start Date : December 2016
Actual Primary Completion Date : July 15, 2017
Actual Study Completion Date : August 14, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Dulaglutide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dulaglutide 4.5mg
4.5mg of Dulaglutide administered subcutaneously (SC)
 Drug: Dulaglutide
Administered SC
Other Name: LY2189265
Experimental: Dulaglutide 3.0mg
3.0mg of Dulaglutide administered SC
 Drug: Dulaglutide
Administered SC
Other Name: LY2189265
Active Comparator: Dulaglutide 1.5mg
1.5mg of Dulaglutide administered SC
 Drug: Dulaglutide
Administered SC
Other Name: LY2189265
Placebo Comparator: Placebo
Placebo administered SC
 Drug: Placebo
Administered SC


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 18 ]

    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

    Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline as a covariate, pooled country, treatment, time, treatment*time as fixed effects.



Secondary Outcome Measures :
  1. Percentage of Participants With HbA1c of <7.0% [ Time Frame: Week 18 ]
    Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

  2. Change From Baseline in Fasting Serum Glucose (FSG) [ Time Frame: Baseline, Week 18 ]
    Fasting serum glucose (FSG) is a test to determine how much glucose (sugar) is in a serum sample after an overnight fast. Least Squares (LS) means was determined by MMRM methodology with baseline as a covariate, pooled country, baseline HbA1c strata using >=8% as cutoff, treatment, time, treatment*time as fixed effects.

  3. Change From Baseline in Body Weight [ Time Frame: Baseline, Week 18 ]
    Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline as a covariate, pooled country, baseline HbA1c strata using >=8% as cutoff, treatment, time, treatment*time as fixed effects.

  4. Percentage of Participants Discontinuing Study Drug Due to Adverse Events [ Time Frame: Baseline through Week 18 ]
    Adverse event (AE) defined as any unfavorable medical event, newly emerged or a deterioration of a preexisting condition, in other words any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship, that occurred after the visit for informed consent and up to the visit for completion of administration, or discontinuation.

  5. Rate of Documented Symptomatic Hypoglycemia [ Time Frame: Week 18 ]
    Hypoglycemic events (HE) were classified as severe, documented symptomatic (defined as an HE with typical symptoms of hypoglycemia and a blood glucose level of ≤3.9 millimoles per liter [mmol/L]). Hypoglycemia rate per 30 days was summarized at each visit by treatment group. The rate of hypoglycemia was analyzed using a generalized estimation equations model with a negative binomial distribution and a Log link. LS mean was determined by MMRM methodology with baseline hypoglycemia rate, pooled country, HbA1c at Baseline, treatment, with log of exposure in days divided by 365.25 as the offset.

  6. Pharmacokinetics (PK): The Maximum Drug Concentration at Steady State (Cmax,ss) of Dulaglutide [ Time Frame: 0, 2, 4, 6, 10, 18, 22 weeks and early termination ]
    Plasma samples for PK analysis were combined measure obtained from 0, 2, 4, 6, 10, 18, 22 weeks and until early termination of the visit. Cmax takes all time points post dose into account and one value was reported.

  7. Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 168 Hours (AUC[0-168], ss) of Dulaglutide [ Time Frame: 0, 2, 4, 6, 10, 18, 22 weeks and early termination ]
    AUC[0-168h] is a combined measure obtained from 0, 2, 4, 6, 10, 18, 22 weeks and until early termination of the visit.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have had type 2 diabetes (T2D) for ≥6 months according to the World Health Organization (WHO) classification
  • Have HbA1c of 7.0% to 10.0%, inclusive, as assessed by the central laboratory
  • Have been treated with stable doses of metformin for at least 3 months
  • Have a body mass index (BMI) ≥25 kilograms per square meter

Exclusion Criteria:

  • Have type 1 diabetes (T1D)
  • Have used any glucose-lowering medication other than metformin 3 months prior to study entry or during screening/lead-in period or have used any glucagon-like peptide-1 receptor agonists (GLP-1 RAs) at any time in the past
  • Have had any of the following cardiovascular conditions: acute myocardial infarction (MI), New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident (stroke)
  • Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (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
  • Have had chronic or acute pancreatitis any time prior to study entry
  • Have an estimated glomerular filtration rate (eGFR) <45 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation
  • Have serum calcitonin ≥20 picograms per milliliter, as determined by the central laboratory at study entry
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02973100


Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Statistical Analysis Plan  [PDF] December 8, 2016
Study Protocol  [PDF] November 7, 2016

More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02973100    
Other Study ID Numbers: 16568
H9X-MC-GBGJ ( Other Identifier: Eli Lilly and Company )
2016-002494-34 ( EudraCT Number )
First Posted: November 25, 2016    Key Record Dates
Results First Posted: August 24, 2018
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Dulaglutide
Hypoglycemic Agents
Physiological Effects of Drugs