Diabetes Mellitus, Type 2Phase 3AWARD-2NCT01075282
A Study in Participants With Type 2 Diabetes Mellitus (AWARD-2)
A Phase 3 study testing Insulin Glargine, LY2189265 and Metformin in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 78 sites in 20 countries.
Trial summary
The purpose of this study is to determine if LY2189265 is effective in reducing hemoglobin A1c (HbA1c) and safe, as compared to Insulin Glargine in participants with Type 2 Diabetes. Participants must also be taking metformin and glimepiride. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin Glargine, LY2189265 and Metformin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 810 participants
- Where
- 78 sitesin 20 countries
- Study dates
- Feb 2010to Nov 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes not well controlled on 1, 2, or 3 oral antidiabetic medications (at least one of them must be metformin and/or a sulfonylurea)
- Glycosylated hemoglobin (HbA1c) greater than or equal to 7 and less than or equal to 11 if taking 1 oral antidiabetic medication
- HbA1c greater than or equal to 7 and less than or equal to 10 if on 2 or 3 oral antidiabetic medications
- Accept treatment with metformin and glimepiride throughout the study, as per protocol
- Willing to inject subcutaneous medication once weekly for LY2189265 or once daily for Insulin Glargine.
- Stable weight for 3 months prior to screening
- Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m^2)
- Females of child bearing potential must test negative for pregnancy at screening by serum pregnancy test and be willing to use a reliable method of birth control during the study and for 1 month following the last dose of study drug
Who cannot join
- Type 1 Diabetes
- HbA1c equal to or less than 6.5 at randomization
- Chronic insulin use
- Taking drugs to promote weight loss by prescription or over the counter
- Taking systemic steroids for greater than 14 days except for topical, eye, nasal, or inhaled
- History of Heart Failure New York Heart Classification III or IV, or acute myocardial infarction, or stroke within 2 months of screening
Show all 19Show fewer
- Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking drugs that directly affect GI motility
- Hepatitis or liver disease or ALT (alanine transaminase) greater than 3.0 of upper normal limit
- Acute or chronic pancreatitis of any form
- Renal disease (kidney) with a serum creatinine of greater than or equal to 1.5 milligrams per deciliter (mg/dL) for males and greater than or equal to 1.4 mg/dL for females, or a creatinine clearance of less than 60 milliliters per minute (ml/min)
- History (includes family) of type 2A or 2B Multiple Endocrine Neoplasia (MEN 2A or 2B) or medullary c-cell hyperplasia or thyroid cancer
- A serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/ml) at screening
- Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis
- History of or active malignancy except skin or in situ cervical or prostate cancer for within last 5 years
- Sickle cell, hemolytic anemia, or other hematological condition that may interfere with HbA1c testing
- Organ transplant except cornea
- Have enrolled in another clinical trial within the last 30 days
- Have previously signed an informed consent or participated in a LY2189265 study
- Have taken a glucagon-like peptide 1 (GLP-1) receptor agonist within the 3 months prior to screening
Trial locations and contacts
78 sites in 20 countries.
78 sites in 20 countries
Canada8 sites
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Coquitlam, British Columbia, V3K 3P4
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Edmonton, Alberta, T5J 3N4
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Markham, Ontario, L6B 0P9
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Mississauga, Ontario, L5M 2V8
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Montreal, Quebec, H2W 1R7
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Sherbrooke, Quebec, J1G 5K2
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St. John's, Newfoundland and Labrador, A1E 2C2
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Winnipeg, Manitoba, R3E 3P4
India7 sites
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Aligarh, 202002
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Bangalore, 560003
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Chennai, 600029
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Indore, 452002
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Jaipur, 302001
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Mumbai, 400053
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Patna, 800 020
Poland6 sites
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Bialystok, 15-404
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Bydogoszcz, 85-094
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Krakow, 31-261
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Szczecin, 71-455
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Warsaw, 02-507
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Wroclaw, 50-127
Taiwan6 sites
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Chiayi City, 600
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Kaohsiung City, 807
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Tainan, 70403
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Taipei, 11031
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Taoyuan, 333
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Yung-Kang, Tainan, 710
Australia5 sites
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Brisbane, Queensland, 4029
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East Ringwood, Victoria, 3135
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Heidelberg, Victoria, 3081
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Keswick, South Australia, 5035
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Wollongong, New South Wales, 2500
France5 sites
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Corbeil-Essonnes, 91106
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Dijon, 21079
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Nantes, 44093
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Pessac, 33604
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Tours, 37044
Argentina4 sites
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Buenos Aires, C1425AGC
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Caba, C1417EYG
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Córdoba, 5006
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Mendoza, 5500
Hungary4 sites
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Budapest, 1036
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Makó, 6900
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Mosonmagyaróvár, 9200
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Székesfehérvár, 8000
Mexico4 sites
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Coatzacoalcos, 96400
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Cuernavaca, 62250
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Guadalajara, 44656
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Monterrey, 64570
Romania4 sites
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Baia Mare, 430123
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Bucharest, 020045
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Galati, 800587
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Oradea, 410025
Spain4 sites
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Alicante, 03114
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Ávila, 05004
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Palencia, 34005
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Requena, 46340
Sweden4 sites
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Gothenburg, 41345
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Helsingborg, 25187
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Lund, 22185
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Stockholm, 11157
Belgium3 sites
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Gribomont, 6887
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Halen, 3545
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Leuven, 3000
Croatia3 sites
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Osijek, 31000
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Slavonski Brod, 35 000
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Zagreb, 10000
South Korea3 sites
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Bucheon-si, 420-717
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Ilsan, 411706
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Pusan, 614-735
Brazil2 sites
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Joinville, 89201-260
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São Paulo, 05403-900
Czechia2 sites
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Holešov, 769 01
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Prague, 140 59
Italy2 sites
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Florence, 50141
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Milan, 20132
Greece1 site
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Athens, 11527
Slovakia1 site
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Košice, 04001
About this study
Official title: A Randomized, Open-Label, Parallel-Arm, Noninferiority Comparison of the Effects of Two Doses of LY2189265 and Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Glimepiride
The purpose of this study is to determine if LY2189265 is effective in reducing hemoglobin A1c (HbA1c) and safe, as compared to Insulin Glargine in participants with Type 2 Diabetes. Participants must also be taking metformin and glimepiride.
Read the detailed description
Rescue therapy refers to 1 of 2 types of additional therapy, each given for a different reason: any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who received rescue therapy were included in the analysis population, but only measurements obtained prior to the beginning of rescue therapy were included in specified efficacy analyses.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin Glargine, LY2189265, Metformin, Glimepiride
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin GlargineDrug
LY2189265Drug
Also called Dulaglutide
MetforminDrug
GlimepirideDrug
| Study group | Role | What they receive |
|---|---|---|
| LY2189265 1.5 mg | Experimental | LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks Receives: Drug: LY2189265; Drug: Metformin; Drug: Glimepiride |
| LY2189265 0.75 mg | Experimental | LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks Receives: Drug: LY2189265; Drug: Metformin; Drug: Glimepiride |
| Insulin Glargine | Active comparator | Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks Receives: Drug: Insulin Glargine; Drug: Metformin; Drug: Glimepiride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)
Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.
Measured: Baseline, 52 weeks
Secondary outcomes (25)
Change From Baseline to 26 Weeks and 78 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)
Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.
Measured: Baseline, 26 weeks, and 78 weeks
Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% at 26, 52 and 78 Weeks
Number of participants achieving HbA1c levels less than 7.0% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.
Measured: 26, 52, and 78 weeks
Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than or Equal to 6.5% at 26, 52 and 78 Weeks
Number of participants achieving HbA1c levels less than or equal to 6.5% was analyzed with a logistic regression model with baseline, country, and treatment as factors included in the model.
Measured: 26, 52, and 78 weeks
Change From Baseline to 26, 52 and 78 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles
The self-monitored blood glucose (SMBG) data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; bedtime; and 3 AM or 5 hours after bedtime. Least Squares (LS) means of the mean of the 8 time points (Daily Mean) were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, 26, 52, and 78 weeks
Change From Baseline to 52 and 78 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)
The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (β)-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population for both HOMA2-B and HOMA-2S were set at 100%. Least Squares (LS) means of change from baseline of C-peptide based HOMA2-%B and HOMA2-%S were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, 52, and 78 weeks
Change From Baseline to 52 and 78 Weeks in Glucagon Concentration
Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.
Measured: Baseline, 52, and 78 weeks
Change From Baseline to 26, 52 and 78 Weeks for Body Weight
Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.
Measured: Baseline, 26, 52, and 78 weeks
Change From Baseline to 26, 52 and 78 Weeks for Body Mass Index
Body mass index (BMI) is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, 26, 52, and 78 weeks
Change From Baseline to 26, 52 and 78 Weeks in the EuroQol 5 Dimension
The European Quality of Life - 5 dimensions (EQ-5D) questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. It consists of 2 parts: the first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 3 possible levels of response (no problem, some problem, or extreme problem). These dimensions are converted into a weighted health-state Index Score. The EQ-5D United Kingdom (UK) score ranges from -0.59 to 1.0, where a score of 1.0 indicates perfect health and negative values are valued as worse than dead. The second part of the questionnaire consists of a 100-mm visual analog scale (VAS) on which the participants rated their perceived health state on that day from 0 (worst imaginable health state) to 100 (best imaginable health). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) and adjusted by treatment, country, and baseline.
Measured: Baseline, 26, 52, and 78 weeks
Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Activities of Daily Living
The Impact of Weight on Activities of Daily Living questionnaire (renamed the Ability to Perform Physical Activities of Daily Living Questionnaire [APPADL]) contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = "not at all difficult" and 1 = "unable to do". The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.
Measured: Baseline, 26, 52, and 78 weeks
Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Self-Perception
The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.
Measured: Baseline, 26, 52, and 78 weeks
Change From Baseline to 26, 52 and 78 Weeks in the Low Blood Sugar Survey
The Low Blood Sugar Survey (LBSS) contains 33 items comprised of 2 subscales (behavior and worry), each of which is rated on a 5-point numeric rating scale from 0 (never) to 4 (almost always). It captures behavioral changes associated with the concerns and experiences of hypoglycemia and the degree to which participants are worried about certain aspects associated with hypoglycemia during the previous 4 weeks. The behavior (or avoidance) subscale has 15 items, and the worry (or affect) subscale has 18 items. Subscale scores are calculated by summing participant responses to items (behavior range 0-60; worry range 0-72). A total score is calculated as the sum of both subscales (range 0-132). Higher scores indicate greater negative impact on subscales and total score. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline as a covariate.
Measured: Baseline, 26, 52, and 78 weeks
Number of Participants With Treatment Emergent Adverse Events at 26, 52 and 78 Weeks
A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: 26, 52, and 78 weeks
Number of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks
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 feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<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 is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through 26, 52, and 78 weeks
Rate of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks
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 feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<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 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through 26, 52, and 78 weeks
Number of Participants Requiring Additional Intervention Due to Hyperglycemia at 26, 52 and 78 Weeks
Additional intervention was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. The number of participants requiring additional intervention due to hyperglycemia is summarized cumulatively at 26, 52, and 78 weeks.
Measured: 26, 52, and 78 weeks
Change From Baseline to 26, 52 and 78 Weeks on Pancreatic Enzymes
Amylase (total and pancreas-derived) and lipase concentrations were measured.
Measured: Baseline, 26, 52, and 78 weeks
Number of Participants With Adjudicated Pancreatitis at 26, 52 and 78 Weeks
The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through 26, 52, and 78 weeks
Change From Baseline to 26, 52 and 78 Weeks on Serum Calcitonin
Measured: Baseline, 26, 52, and 78 weeks
Number of Participants With Adjudicated Cardiovascular Events at 26, 52 and 78 Weeks
Information on cardiovascular (CV) risk factors was collected at baseline. Data on any new CV event was prospectively collected using a CV event electronic case report form. At prespecified visits, participants were asked about any new CV event. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include 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. The number of participants with adjudicated CV events is summarized cumulatively at 26, 52, and 78 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through 26, 52, and 78 weeks
Change in Baseline to 26, 52 and 78 Weeks on Pulse Rate
Sitting pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, 26, 52, and 78 weeks
Change From Baseline to 26, 52, and 78 Weeks on Blood Pressure
Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, 26, 52, and 78 weeks
Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Heart Rate
Electrocardiogram (ECG) heart rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, 26, 52, and 78 weeks
Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval
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. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, 26, 52, and 78 weeks
Number of Participants With LY2189265 Antibodies at 26, 52, 78 Weeks and 4 Weeks After Last Dose of Study Drug (83 Weeks Maximum)
LY2189265 (Dulaglutide) anti-drug antibodies (ADA) were assessed at baseline, 26, 52, and 78 weeks, and at the safety follow-up visit 30 days after study drug discontinuation (83 weeks). The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA at each time point were summarized.
Measured: Baseline, 26, 52, 78, and 83 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 810 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075282
- Sponsor's protocol ID
- 11374
- Other IDs
- H9X-MC-GBDB
- Acronym
- AWARD-2
- Status last verified
- Jan 2015
- First submitted
- 23 Feb 2010
- Last updated
- 16 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Boustani MA, Pittman I 4th, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged >/=65 and <65 years. Diabetes Obes Metab. 2016 Aug;18(8):820-8. doi: 10.1111/dom.12687. Epub 2016 Jun 7.
PubMed 27161178Yu M, Van Brunt K, Varnado OJ, Boye KS. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Diabetes Obes Metab. 2016 Apr;18(4):419-24. doi: 10.1111/dom.12624. Epub 2016 Feb 4.
PubMed 26691396Giorgino F, Benroubi M, Sun JH, Zimmermann AG, Pechtner V. Efficacy and Safety of Once-Weekly Dulaglutide Versus Insulin Glargine in Patients With Type 2 Diabetes on Metformin and Glimepiride (AWARD-2). Diabetes Care. 2015 Dec;38(12):2241-9. doi: 10.2337/dc14-1625. Epub 2015 Jun 18.
PubMed 26089386
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Parallel-Arm, Noninferiority Comparison of the Effects of Two Doses of LY2189265 and Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes on Stable Doses of Metformin and Glimepiride
- ClinicalTrials.gov ID
- NCT01075282
- Acronym / sponsor ID
- AWARD-2 / 11374
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 810 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 25 Feb 2010 (estimated)
- Results
- Posted 16 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if LY2189265 is effective in reducing hemoglobin A1c (HbA1c) and safe, as compared to Insulin Glargine in participants with Type 2 Diabetes. Participants must also be taking metformin and glimepiride.
Detailed description
Rescue therapy refers to 1 of 2 types of additional therapy, each given for a different reason: any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who received rescue therapy were included in the analysis population, but only measurements obtained prior to the beginning of rescue therapy were included in specified efficacy analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LY2189265 1.5 mg | Experimental | Drug: LY2189265, Drug: Metformin, Drug: GlimepirideLY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks Glimepiride: at least 4 mg/day, oral, for 78 weeks |
| LY2189265 0.75 mg | Experimental | Drug: LY2189265, Drug: Metformin, Drug: GlimepirideLY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks Glimepiride: at least 4 mg/day, oral, for 78 weeks |
| Insulin Glargine | Active comparator | Drug: Insulin Glargine, Drug: Metformin, Drug: GlimepirideInsulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks Glimepiride: at least 4 mg/day, oral, for 78 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Type 2 Diabetes not well controlled on 1, 2, or 3 oral antidiabetic medications (at least one of them must be metformin and/or a sulfonylurea)
- Accept treatment with metformin and glimepiride throughout the study, as per protocol
- Willing to inject subcutaneous medication once weekly for LY2189265 or once daily for Insulin Glargine.
- Stable weight for 3 months prior to screening
- Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m^2)
Key exclusion criteria (19 listed)
- Type 1 Diabetes
- HbA1c equal to or less than 6.5 at randomization
- Chronic insulin use
- Taking drugs to promote weight loss by prescription or over the counter
- Taking systemic steroids for greater than 14 days except for topical, eye, nasal, or inhaled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin Glargine | Drug | Insulin Glargine |
| LY2189265Also: Dulaglutide | Drug | LY2189265 0.75 mg, LY2189265 1.5 mg |
| Metformin | Drug | Insulin Glargine, LY2189265 0.75 mg, LY2189265 1.5 mg |
| Glimepiride | Drug | Insulin Glargine, LY2189265 0.75 mg, LY2189265 1.5 mg |
Primary outcome
Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline, 52 weeks
Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country and treatment as fixed effects and baseline HbA1c as a covariate.
25 secondary outcomes
Change From Baseline to 26 Weeks and 78 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline, 26 weeks, and 78 weeks
Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% at 26, 52 and 78 Weeks
Time frame: 26, 52, and 78 weeks
Number of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than or Equal to 6.5% at 26, 52 and 78 Weeks
Time frame: 26, 52, and 78 weeks
Change From Baseline to 26, 52 and 78 Weeks for Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles
Time frame: Baseline, 26, 52, and 78 weeks
Change From Baseline to 52 and 78 Weeks in Updated Homeostasis Model Assessment of Beta-cell Function (HOMA2-%B) and Updated Homeostasis Model Assessment of Insulin Sensitivity (HOMA2-%S)
Time frame: Baseline, 52, and 78 weeks
Change From Baseline to 52 and 78 Weeks in Glucagon Concentration
Time frame: Baseline, 52, and 78 weeks
Change From Baseline to 26, 52 and 78 Weeks for Body Weight
Time frame: Baseline, 26, 52, and 78 weeks
Change From Baseline to 26, 52 and 78 Weeks for Body Mass Index
Time frame: Baseline, 26, 52, and 78 weeks
Change From Baseline to 26, 52 and 78 Weeks in the EuroQol 5 Dimension
Time frame: Baseline, 26, 52, and 78 weeks
Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Activities of Daily Living
Time frame: Baseline, 26, 52, and 78 weeks
Change From Baseline to 26, 52 and 78 Weeks in the Impact of Weight on Self-Perception
Time frame: Baseline, 26, 52, and 78 weeks
Change From Baseline to 26, 52 and 78 Weeks in the Low Blood Sugar Survey
Time frame: Baseline, 26, 52, and 78 weeks
Number of Participants With Treatment Emergent Adverse Events at 26, 52 and 78 Weeks
Time frame: 26, 52, and 78 weeks
Number of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks
Time frame: Baseline through 26, 52, and 78 weeks
Rate of Self-reported Hypoglycemic Events at 26, 52 and 78 Weeks
Time frame: Baseline through 26, 52, and 78 weeks
Number of Participants Requiring Additional Intervention Due to Hyperglycemia at 26, 52 and 78 Weeks
Time frame: 26, 52, and 78 weeks
Change From Baseline to 26, 52 and 78 Weeks on Pancreatic Enzymes
Time frame: Baseline, 26, 52, and 78 weeks
Number of Participants With Adjudicated Pancreatitis at 26, 52 and 78 Weeks
Time frame: Baseline through 26, 52, and 78 weeks
Change From Baseline to 26, 52 and 78 Weeks on Serum Calcitonin
Time frame: Baseline, 26, 52, and 78 weeks
Number of Participants With Adjudicated Cardiovascular Events at 26, 52 and 78 Weeks
Time frame: Baseline through 26, 52, and 78 weeks
Change in Baseline to 26, 52 and 78 Weeks on Pulse Rate
Time frame: Baseline, 26, 52, and 78 weeks
Change From Baseline to 26, 52, and 78 Weeks on Blood Pressure
Time frame: Baseline, 26, 52, and 78 weeks
Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Heart Rate
Time frame: Baseline, 26, 52, and 78 weeks
Change From Baseline to 26, 52 and 78 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval
Time frame: Baseline, 26, 52, and 78 weeks
Number of Participants With LY2189265 Antibodies at 26, 52, 78 Weeks and 4 Weeks After Last Dose of Study Drug (83 Weeks Maximum)
Time frame: Baseline, 26, 52, 78, and 83 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27161178Boustani MA, Pittman I 4th, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged >/=65 and <65 years. Diabetes Obes Metab. 2016 Aug;18(8):820-8. doi: 10.1111/dom.12687. Epub 2016 Jun 7.
- Derived from this study: PubMed 26691396Yu M, Van Brunt K, Varnado OJ, Boye KS. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Diabetes Obes Metab. 2016 Apr;18(4):419-24. doi: 10.1111/dom.12624. Epub 2016 Feb 4.
- Derived from this study: PubMed 26089386Giorgino F, Benroubi M, Sun JH, Zimmermann AG, Pechtner V. Efficacy and Safety of Once-Weekly Dulaglutide Versus Insulin Glargine in Patients With Type 2 Diabetes on Metformin and Glimepiride (AWARD-2). Diabetes Care. 2015 Dec;38(12):2241-9. doi: 10.2337/dc14-1625. Epub 2015 Jun 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
78 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin Glargine, LY2189265 and Metformin in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 78 sites in 20 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 sites in Canada, India, Poland, Taiwan, Australia and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) (time frame: Baseline, 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01075282, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2015.