A Study Comparing the Effects and Safety of Dulaglutide With Insulin Glargine in Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01648582
First received: July 16, 2012
Last updated: December 21, 2015
Last verified: December 2015
  Purpose
The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe compared to once-daily insulin glargine in participants with type 2 diabetes mellitus who have inadequate glycemic control with 1 or 2 oral antihyperglycemic medications (OAM) (metformin and/or a sulfonylurea), in addition to any healthy lifestyle changes recommended by their healthcare providers.

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Dulaglutide
Drug: Insulin glargine
Drug: Metformin
Drug: Sulfonylureas
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Once-Weekly, Subcutaneous Dulaglutide Compared to Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Mellitus on Metformin and/or a Sulfonylurea

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
    HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) means of change from baseline in HbA1c were calculated using a mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, baseline HbA1c, country, oral antihyperglycemic medication (OAM) , visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect.


Secondary Outcome Measures:
  • Change From Baseline in HbA1c at 52 Weeks [ Time Frame: Baseline, 52 Weeks ] [ Designated as safety issue: No ]
    HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS means of change from baseline in HbA1c were calculated using a MMRM with the change in HbA1c as the dependent variable and treatment, baseline HbA1c, country, OAM, visit, and treatment-by-visit interaction as fixed effects, and participant was as the random effect.

  • Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks and 52 Weeks [ Time Frame: Up to 26 and 52 weeks ] [ Designated as safety issue: No ]
    The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.

  • Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: No ]
    LS means of change from baseline were calculated using MMRM with the change in FBG as the dependent variable and treatment, baseline value, country, OAM, visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect.

  • Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks and 52 Weeks [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: No ]
    Participants were required to perform 7-point SMBG profiles on 2 separate, nonconsecutive days during the 2 weeks before randomization and Weeks 8, 14, 20, 26, 39, and 52 (or the Early Discontinuation Visit). SMBG measurements were taken using a plasma-equivalent blood glucose (BG) meter at 7 time points: 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. Mean and Week 26 and Week 52 was assessed in all treatment groups. LS means of change from baseline were calculated using MMRM with the change in 7-point SMBG as the dependent variable and treatment, baseline value, country, OAM, visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect.

  • Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weeks and 52 Weeks [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
    The updated Homeostasis Model Assessment (HOMA2) was used to quantify steady state beta-cell function (%B). HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate %B as a percentage of a normal reference population. LS means were calculated using an analysis of covariance (ANCOVA) model with change from baseline in HOMA-%B as a covariate and country, baseline measurement, OAM, and treatment as fixed effects.

  • Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks and 52 Weeks [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: No ]
    The HOMA2 was used to estimate the steady-state insulin sensitivity (%S). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as a percentage of the normal reference population. LS means were calculated using an ANCOVA model with change from baseline in HOMA-%S as a covariate and country, baseline measurement, OAM, and treatment as fixed effects.

  • Rate of Hypoglycemic Events [ Time Frame: Baseline through 26 weeks and 52 weeks ] [ Designated as safety issue: Yes ]
    Hypoglycemic events (HE) were classified as documented symptomatic hypoglycemia, asymptomatic hypoglycemia, severe hypoglycemia, and probable symptomatic hypoglycemia. The 1-year adjusted rate of HEs was summarized cumulatively at 26 weeks and 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

  • Number of Self-reported Hypoglycemic Events [ Time Frame: Baseline through 26 Weeks and 52 Weeks ] [ Designated as safety issue: Yes ]
    Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia, and had a plasma glucose level of less than or equal to 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events was summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

  • Change From Baseline to 26 Weeks and 52 Weeks on Blood Pressure (BP) [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: Yes ]
    Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. LS means of change from baseline were calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.

  • Change From Baseline at 26 Weeks and 52 Weeks on Pulse Rate [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: Yes ]
    Seated pulse rate was measured. LS means of change from baseline were calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.

  • Change From Baseline in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: Yes ]
    The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. LS means of change from baseline were calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.

  • Change From Baseline in Electrocardiogram Parameters, Heart Rate (HR) [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: Yes ]
    Descriptive statistics for the actual measurements and LS means of change from baseline for HR (sitting) by treatment arm were analyzed using the analysis of variance (ANOVA) model with treatment, country, visit, and treatment-by-visit interaction as fixed effects, baseline rate as a covariate, and participant as a random effect.

  • Change From Baseline in Pancreatic Enzymes [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: Yes ]
    Amylase (total and pancreas-derived) and lipase concentrations were measured

  • Change From Baseline in Serum Calcitonin [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants With Adjudicated Cardiovascular (CV) Events [ Time Frame: Baseline through 52 weeks ] [ Designated as safety issue: Yes ]
    Deaths and nonfatal cardiovascular adverse events were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular events subjected to adjudication included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

  • Number of Participants With Adjudicated Pancreatitis [ Time Frame: Baseline through 26 Weeks and 52 Weeks ] [ Designated as safety issue: Yes ]
    Events of pancreatitis (including suspected pancreatitis and severe or serious abdominal pain) were adjudicated by a committee of expert physicians external to the Sponsor. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

  • Change From Baseline in Body Weight [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: No ]
  • Change in Body Mass Index [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: No ]
    Body mass index is an estimate of body fat based on body weight divided by height squared.

  • Percentages of Participants Developing Treatment-Emergent Dulaglutide Anti-drug Antibody (ADA) [ Time Frame: Baseline through 52 Weeks ] [ Designated as safety issue: No ]
    Number of participants with treatment emergent (TE) dulaglutide anti-drug antibodies from postbaseline to follow up were summarized. A participant was considered to have TE dulaglutide ADA if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.

  • EQ-5D Health State Score Responses [ Time Frame: Baseline, 26 Weeks, 52 Weeks ] [ Designated as safety issue: No ]
    The EQ-5D questionnaire is a widely used, generic questionnaire that assesses health-related quality of life. It consists of 2 parts. The first part assesses 5 dimensions associated with quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 possible levels of response: no problem, some problem, and extreme problem. Additional categories of response include ambiguous and missing. The number of participants per each of the 3 response categories is summarized for each of the 5 dimensions.

  • Change From Baseline in EQ-5D Visual Analog Scale Score [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
    The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score was self-reported using a visual analogue scale (VAS) marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. LS means of change from baseline were calculated using ANCOVA and adjusted by treatment, country, and baseline.


Enrollment: 789
Study Start Date: July 2012
Study Completion Date: December 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1.5 mg Dulaglutide
1.5 milligrams (mg) dulaglutide administered as one subcutaneous (SC) injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea for up to 52 weeks. Participants are blinded to the dulaglutide dose.
Drug: Dulaglutide
Administered SC
Other Name: LY2189265
Drug: Metformin
Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
Drug: Sulfonylureas
Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
Experimental: 0.75 mg Dulaglutide
0.75 mg Dulaglutide administered as one SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea for up to 52 weeks. Participants are blinded to the dulaglutide dose.
Drug: Dulaglutide
Administered SC
Other Name: LY2189265
Drug: Metformin
Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
Drug: Sulfonylureas
Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
Active Comparator: Insulin Glargine
Insulin glargine administered based on fasting blood glucose concentrations per the dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and /or a sulfonylurea for up to 52 weeks.
Drug: Insulin glargine
Administered SC per dosing titration schedule
Drug: Metformin
Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
Drug: Sulfonylureas
Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have type 2 diabetes mellitus for at least 6 months
  • Have been taking metformin and/or a sulfonylurea for at least 3 months before screening and have been on a stable therapeutic dose for at least 8 weeks
  • Glycosylated hemoglobin (HbA1c) value of ≥7.0% to ≤11.0%
  • Adult men or adult non-pregnant, non-breastfeeding women
  • Body Mass Index (BMI) of ≥19.0 to ≤35.0 kilograms/square meter (kg/m^2)
  • Stable weight (±5%) ≥3 months prior to screening

Exclusion Criteria:

  • Have type 1 diabetes mellitus
  • Have previous treatment with a glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1 analog, or any other incretin mimetic
  • Have treatment with dipeptidyl peptidase-IV (DPP-IV) inhibitor, an alpha-glucosidase inhibitor (AGI), thiazolidinedione (TZD), or glinide
  • Have gastric emptying abnormality
  • Have cardiac disorder defined as unstable angina, myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, heart failure, arrhythmia, transient ischemic attack, or stroke
  • Have poorly controlled hypertension (systolic blood pressure above 160 millimeter of mercury[mmHg] or diastolic blood pressure above 95 mmHg)
  • Have impaired liver function
  • Have impaired kidney function
  • Have history of chronic pancreatitis or acute pancreatitis
  • Have a serum calcitonin ≥20 picograms per milliliter (pg/mL)
  • Have a personal or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma, or multiple endocrine neoplasia type 2 (MEN 2)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01648582

Locations
China
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Beijing, China, 100730
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Changsha, China, 410011
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Chengdu, China, 610041
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Chongqing, China, 400030
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Dalian, China, 116011
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Guang Zhou, China, 510120
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Guiyang, China, 550004
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Hangzhou, China, 310009
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Harbin, China, 150001
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Hefei, China, 230022
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Nanchang, China, 330006
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Nanjing, China, 210006
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Nanning, China, 530021
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Shanghai, China, 200080
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Shenyang, China, 110004
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Shijiazhuang, China, 050051
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Wu Han, China, 430022
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Xi'An, China, 710032
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Yangzhou, China, 225001
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Zhenjiang, China, 212000
Korea, Republic of
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Bucheon,, Korea, Republic of, 420-717
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Kyunggi-Do, Korea, Republic of, 425-020
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Seoul, Korea, Republic of, 137-701
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Wonju-Si, Korea, Republic of, 220-701
Mexico
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Chihuahua, Mexico, 31238
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Monterrey, Mexico, 64460
Russian Federation
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Chelyabinsk, Russian Federation, 454047
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Moscow, Russian Federation, 127018
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Saint Petersburg, Russian Federation, 192012
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Sankt-Petersburg, Russian Federation, 190000
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01648582     History of Changes
Other Study ID Numbers: 13439  H9X-CR-GBDK 
Study First Received: July 16, 2012
Results First Received: May 8, 2015
Last Updated: December 21, 2015
Health Authority: China: Food and Drug Administration
Korea: Food and Drug Administration
Russia: Ministry of Health of the Russian Federation
Mexico: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glargine
Immunoglobulin Fc Fragments
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Metformin
Hypoglycemic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 02, 2016