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Trial · Interventional

CompletedPhase 2Results postedRegistry data

A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes

NCTNCT02119819 (opens ClinicalTrials.gov in a new tab)Other id15062Other id2013-003552-21Other idI7I-MC-XNAA
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
420 participants (actual)
Sponsor
OPKO Health, Inc. · Industry
Design
Randomized · Double masking
Countries
6 countries

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

Start
Apr 2014
Primary completion
Aug 2015
Completion
Oct 2015
First posted
22 Apr 2014 (estimated)
Last update posted
27 May 2021
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016
  1. Ph 2

    A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes

    NCT02119819

    Apr 2014 to Oct 2015

Registry summary

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

The main purpose of this study is to compare the safety and effectiveness of the study drug known as LY2944876 to exenatide extended-release and placebo in participants with type 2 diabetes mellitus. All drugs will be given by an injection under the skin. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. Participants' involvement in the study is expected to last about 30 weeks.

Interventions

  • LY2944876Drug
  • Exenatide extended-releaseDrug
  • PlaceboDrug
  • MetforminDrug

Arms6

  • Experimental

    10 mg LY2944876

    10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.

  • Experimental

    15 mg LY2944876

    15 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.

  • Experimental

    30 mg LY2944876

    30 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.

  • Experimental

    50 mg LY2944876

    50 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.

  • Experimental

    Exenatide extended-release

    2 mg exenatide extended-release given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.

  • Placebo comparator

    Placebo

    Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12

    Time frame · Baseline, Week 12

    Registry description

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

Secondary outcomes(14)

  1. Change From Baseline in HbA1c at Week 24

    Time frame · Baseline, Week 24

    Registry description

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

  2. Percent Change From Baseline in Body Weight

    Time frame · Baseline, Week 12; Baseline, Week 24

  3. Change From Baseline in Fasting Blood Glucose

    Time frame · Baseline, Week 12; Baseline, Week 24

    Registry description

    Least square means (LSM) was calculated from mixed-effects model with repeated measures (MMRM) analysis using restricted maximum likelihood (REML) with metformin use, baseline body mass index (BMI) category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline fasting blood glucose as a covariate, and participant as a random effect.

  4. Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values

    Time frame · Baseline, Week (Wk) 12; Baseline, Week 24

    Registry description

    SMBG 7-point profiles were measured at morning pre-meal, morning 2 hours post-meal, mid-day pre-meal, mid-day 2 hours post-meal, evening pre-meal, evening 2 hours post-meal, and at bedtime. LSM were calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline fasting blood glucose as a covariate, and participant as a random effect.

  5. Change From Baseline in Lipids

    Time frame · Baseline, Week 24

    Registry description

    Change from baseline in high-density lipoprotein cholesterol (HDL-C), total cholesterol, triglycerides, and low-density lipoprotein cholesterol (LDL-C). LSM was calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant an a random effect.

  6. Change From Baseline in Fasting Fibroblast Growth Factor 21

    Time frame · Baseline, Week 12; Baseline, Week 24

    Registry description

    LSM was calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect.

  7. Percentage of Participants Requiring Rescue Therapy

    Time frame · Baseline through Therapy Completion (Week 24)

    Registry description

    Participants who received rescue medication with non-study antihyperglycemic medications or change their stable dose of metformin.

  8. Percentage of Participants Developing Anti-Drug Antibodies to LY2944876

    Time frame · Week 12 and Week 24

    Registry description

    Percentage of participants developing anti-drug antibodies to LY2944876.

  9. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2944876

    Time frame · Baseline, Week 8, Week 12, Week 16, Week 20, Week 24

    Registry description

    Evaluable pharmacokinetic concentrations from the specified timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.

  10. Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2944876

    Time frame · Baseline, Week 8, Week 12, Week 16, Week 20, Week 24

    Registry description

    Evaluable pharmacokinetic concentrations from the specified timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.

  11. Change From Baseline in Adiponectin Levels

    Time frame · Baseline, Week 12; Baseline, Week 24

    Registry description

    LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect.

  12. Change From Baseline in Beta-Hydroxy Butyrate Levels

    Time frame · Baseline, Week 12; Baseline, Week 24

    Registry description

    LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect.

  13. Change From Baseline in Glucagon Levels

    Time frame · Baseline, Week 12; Baseline, Week 24

    Registry description

    LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect.

  14. Change From Baseline in Insulin Levels

    Time frame · Baseline, Week 12; Baseline, Week 24

    Registry description

    LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect.

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 outcomeMean· Baseline, Week 12

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12

GroupValue (percentage of HbA1c)Spread
10 mg LY2944876-1.070.12
15 mg LY2944876-1.090.11
30 mg LY2944876-1.440.11
50 mg LY2944876-1.330.11
Exenatide Extended-release-1.420.11
Placebo-0.290.11
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline, Week 24

Change From Baseline in HbA1c at Week 24

GroupValue (percentage of HbA1c)Spread
10 mg LY2944876-0.850.14
15 mg LY2944876-1.140.13
30 mg LY2944876-1.370.13
50 mg LY2944876-1.290.13
Exenatide Extended-release-1.480.13
Placebo-0.380.14
Secondary outcomeMean· Baseline, Week 12; Baseline, Week 24

Percent Change From Baseline in Body Weight

GroupValue (Percentage change)Spread
10 mg LY2944876-1.090.35
15 mg LY2944876-1.860.33
30 mg LY2944876-2.010.33
50 mg LY2944876-3.230.34
Exenatide Extended-release-2.040.35
Placebo-1.220.34
Secondary outcomeLeast squares mean· Baseline, Week 12; Baseline, Week 24

Change From Baseline in Fasting Blood Glucose

GroupValue (milligrams per deciliter (mg/dL))Spread
10 mg LY2944876-20.8814.618
15 mg LY2944876-21.9914.371
30 mg LY2944876-31.3094.305
50 mg LY2944876-28.4054.506
Exenatide Extended-release-39.0744.419
Placebo-1.5884.519
Secondary outcomeLeast squares mean· Baseline, Week (Wk) 12; Baseline, Week 24

Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values

GroupValue (mg/dL)Spread
10 mg LY2944876-26.83.9
15 mg LY2944876-28.43.8
30 mg LY2944876-34.33.7
50 mg LY2944876-34.83.8
Exenatide Extended-release-38.73.8
Placebo-7.43.8
Secondary outcomeLeast squares mean· Baseline, Week 24

Change From Baseline in Lipids

GroupValue (mg/dL)Spread
10 mg LY29448761.561.03
15 mg LY29448760.920.98
30 mg LY29448760.900.96
50 mg LY29448761.041.01
Exenatide Extended-release2.350.990
Placebo2.171.04
Secondary outcomeLeast squares mean· Baseline, Week 12; Baseline, Week 24

Change From Baseline in Fasting Fibroblast Growth Factor 21

GroupValue (microgram per liter (µg/L))Spread
10 mg LY2944876-0.070.071
15 mg LY29448760.060.068
30 mg LY2944876-0.030.068
50 mg LY2944876-0.140.069
Exenatide Extended-release-0.090.069
Placebo-0.110.071
Secondary outcomeNumber· Baseline through Therapy Completion (Week 24)

Percentage of Participants Requiring Rescue Therapy

GroupValue (percentage of participants)
10 mg LY29448766.1
15 mg LY29448762.8
30 mg LY29448762.7
50 mg LY29448764.3
Exenatide Extended-release2.9
Placebo11.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
10 mg LY294487610 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks.–0 / 6634 / 66
15 mg LY294487615 mg LY2944876 given SC once weekly for 24 weeks.–2 / 7147 / 71
30 mg LY294487630 mg LY2944876 given SC once weekly for 24 weeks.–2 / 7339 / 73
50 mg LY294487650 mg LY2944876 given SC once weekly for 24 weeks.–3 / 7046 / 70
Exenatide Extended-release2 mg exenatide extended-release given SC once weekly for 24 weeks.–3 / 6938 / 69
PlaceboPlacebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study.–2 / 7116 / 71

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.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedPark EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19. PMID 30957581

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Men or women with diabetes mellitus Type 2 * Have screening HbA1c ≥7.0% and ≤10.5% either on diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for 3 months prior to screening * Have body mass index (BMI) ≥23 and ≤45 kilograms per meter squared at screening Exclusion Criteria: * Women of child bearing potential * Participants who have used thiazolidinediones within 3 months prior to screening, or any other drugs for treatment of hyperglycemia (except metformin) within the prior 2 months * Participants who have used insulin for diabetic control for more than 6 consecutive days within the prior year * Participants with impaired renal function (serum creatinine \>124 micromole per liter (µmol/L) \[1.4 milligrams per deciliter (mg/dL)\] in women, \>133 µmol/L \[1.5 mg/dL\] in men)

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