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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT02973100 (opens ClinicalTrials.gov in a new tab)Other id16568Other idH9X-MC-GBGJOther id2016-002494-34Other id2016
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
318 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
6 countries

United States, Czechia, Mexico, Poland, Puerto Rico, Romania

Start
Dec 2016
Primary completion
15 Jul 2017
Completion
14 Aug 2017
First posted
25 Nov 2016 (estimated)
Last update posted
23 Sept 2019
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018
  1. Ph 2

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

    NCT02973100

    Dec 2016 to 14 Aug 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • DulaglutideDrug
  • PlaceboDrug

Arms4

  • Experimental

    Dulaglutide 4.5mg

    4.5mg of Dulaglutide administered subcutaneously (SC)

  • Experimental

    Dulaglutide 3.0mg

    3.0mg of Dulaglutide administered SC

  • Active comparator

    Dulaglutide 1.5mg

    1.5mg of Dulaglutide administered SC

  • Placebo comparator

    Placebo

    Placebo administered SC

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Hemoglobin A1c (HbA1c)

    Time frame · Baseline, Week 18

    Registry description

    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 outcomes(7)

  1. Percentage of Participants With HbA1c of <7.0%

    Time frame · Week 18

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    AUC\[0-168h\] is a combined measure obtained from 0, 2, 4, 6, 10, 18, 22 weeks and until early termination of the visit.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, Week 18

Change From Baseline in Hemoglobin A1c (HbA1c)

GroupValue (Percentage of glycosylated hemoglobin)Spread
Placebo-0.440.101
Dulaglutide 1.5mg-1.230.099
Dulaglutide 3.0mg-1.310.099
Dulaglutide 4.5mg-1.400.103
Secondary and other outcome results(7)
Secondary outcomeNumber· Week 18

Percentage of Participants With HbA1c of <7.0%

GroupValue (Percentage of Participants)
Placebo20
Dulaglutide 1.5mg71.2
Dulaglutide 3.0mg71.2
Dulaglutide 4.5mg68.2
Secondary outcomeLeast squares mean· Baseline, Week 18

Change From Baseline in Fasting Serum Glucose (FSG)

GroupValue (millimole/liter (mmol/L))Spread
Placebo-0.690.257
Dulaglutide 1.5mg-2.010.261
Dulaglutide 3.0mg-1.920.250
Dulaglutide 4.5mg-2.110.263
Secondary outcomeLeast squares mean· Baseline, Week 18

Change From Baseline in Body Weight

GroupValue (Kilograms (Kg))Spread
Placebo-1.60.39
Dulaglutide 1.5mg-2.80.39
Dulaglutide 3.0mg-3.90.39
Dulaglutide 4.5mg-4.10.41
Secondary outcomeNumber· Baseline through Week 18

Percentage of Participants Discontinuing Study Drug Due to Adverse Events

GroupValue (Percentage of Participants)
Placebo4.9
Dulaglutide 1.5mg6.2
Dulaglutide 3.0mg10.1
Dulaglutide 4.5mg13.2
Secondary outcomeLeast squares mean· Week 18

Rate of Documented Symptomatic Hypoglycemia

GroupValue (Episodes/participant/365.25 days)Spread
Placebo0.000.000
Dulaglutide 1.5mg0.000.000
Dulaglutide 3.0mg0.000.000
Dulaglutide 4.5mg0.000.001
Secondary outcomeMean· 0, 2, 4, 6, 10, 18, 22 weeks and early termination

Pharmacokinetics (PK): The Maximum Drug Concentration at Steady State (Cmax,ss) of Dulaglutide

GroupValue (nanogram per milliliter (ng/mL))
Dulaglutide 1.5mg90.4
Dulaglutide 3.0mg151
Dulaglutide 4.5mg204
Secondary outcomeMean· 0, 2, 4, 6, 10, 18, 22 weeks and early termination

Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 168 Hours (AUC[0-168], ss) of Dulaglutide

GroupValue (nanogram*hour per milliliter (ng*h/mL))
Dulaglutide 1.5mg11800
Dulaglutide 3.0mg26700
Dulaglutide 4.5mg36600

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlaceboParticipants received placebo once weekly (QW) by subcutaneous (SC) injection.0 / 814 / 8129 / 81
Dulaglutide 1.5mgParticipants received 1.5mg of dulaglutide QW by SC injection.0 / 813 / 8136 / 81
Dulaglutide 3.0mgParticipants received 3.0mg of dulaglutide QW by SC injection.0 / 797 / 7949 / 79
Dulaglutide 4.5mgParticipants received 4.5mg of dulaglutide QW by SC injection.0 / 763 / 7639 / 76

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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