Trial Outcomes & Findings for A Study of Dulaglutide (LY2189265) in Participants With Type II Diabetes (NCT NCT02152371)
NCT ID: NCT02152371
Last Updated: 2019-09-25
Results Overview
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least-squares (LS) mean and standard error (SE) changes from baseline in HbA1c at 28 weeks were measured using mixed model regression and restricted maximum likelihood (REML) with treatment, pooled country, visit, and treatment-by -visit interaction as fixed effects, baseline as covariate, and participant as a random effect.
COMPLETED
PHASE3
300 participants
Baseline, 28 Weeks
2019-09-25
Participant Flow
All eligible participants entered a 2-week lead-in period. Only those participants who required further up-titration of the insulin glargine dose per treat-to-target (TTT) algorithm were randomized to one of two treatment groups.
Participant milestones
| Measure |
Dulaglutide + Insulin Glargine
1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
|
Placebo + Insulin Glargine
Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
150
|
|
Overall Study
Received at Least 1 Dose of Study Drug.
|
150
|
150
|
|
Overall Study
COMPLETED
|
138
|
134
|
|
Overall Study
NOT COMPLETED
|
12
|
16
|
Reasons for withdrawal
| Measure |
Dulaglutide + Insulin Glargine
1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
|
Placebo + Insulin Glargine
Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
7
|
|
Overall Study
Protocol Violation
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Reason Not Given
|
0
|
1
|
Baseline Characteristics
A Study of Dulaglutide (LY2189265) in Participants With Type II Diabetes
Baseline characteristics by cohort
| Measure |
Dulaglutide + Insulin Glargine
n=150 Participants
1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
|
Placebo + Insulin Glargine
n=150 Participants
Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 9.47 • n=5 Participants
|
60.6 years
STANDARD_DEVIATION 10.07 • n=7 Participants
|
60.4 years
STANDARD_DEVIATION 9.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
104 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
143 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
281 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
25 participants
n=5 Participants
|
27 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
12 participants
n=5 Participants
|
16 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
37 participants
n=5 Participants
|
35 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
29 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
13 participants
n=5 Participants
|
15 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
29 participants
n=5 Participants
|
26 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Mean Insulin Glargine Dose
|
40.71 Units (U)
STANDARD_DEVIATION 23.12 • n=5 Participants
|
36.59 Units (U)
STANDARD_DEVIATION 21.46 • n=7 Participants
|
38.65 Units (U)
STANDARD_DEVIATION 22.37 • n=5 Participants
|
|
Metformin Use at Baseline
Treated with Metformin
|
134 participants
n=5 Participants
|
131 participants
n=7 Participants
|
265 participants
n=5 Participants
|
|
Metformin Use at Baseline
Not Treated with Metformin
|
16 participants
n=5 Participants
|
19 participants
n=7 Participants
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 28 WeeksPopulation: All participants who received at least one dose of study drug and had evaluable baseline and post- baseline HbA1c.
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least-squares (LS) mean and standard error (SE) changes from baseline in HbA1c at 28 weeks were measured using mixed model regression and restricted maximum likelihood (REML) with treatment, pooled country, visit, and treatment-by -visit interaction as fixed effects, baseline as covariate, and participant as a random effect.
Outcome measures
| Measure |
Dulaglutide + Insulin Glargine
n=150 Participants
1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
Placebo + Insulin Glargine
n=150 Participants
Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
|---|---|---|
|
Change From Baseline to 28 Weeks in Hemoglobin A1c (HbA1c)
|
-1.44 percentage of change
Standard Error 0.09
|
-0.67 percentage of change
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Baseline, 28 WeeksPopulation: All participants who received at least one dose of study drug and had evaluable baseline and post-baseline FSG data.
FSG is a test to determine glucose levels after an overnight fast. LS means FSG change from baseline to primary endpoint at week 28 was calculated using a mixed effects model for repeated measures (MMRM) analysis adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline FSG as covariate.
Outcome measures
| Measure |
Dulaglutide + Insulin Glargine
n=150 Participants
1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
Placebo + Insulin Glargine
n=150 Participants
Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
|---|---|---|
|
Change From Baseline to 28 Weeks in Fasting Serum Glucose (FSG)
|
-44.63 milligram per deciliter (mg/dL)
Standard Error 4.16
|
-27.90 milligram per deciliter (mg/dL)
Standard Error 4.08
|
SECONDARY outcome
Timeframe: Baseline, 28 WeeksPopulation: All randomized participants who received at least 1 dose of study drug and had evaluable baseline and post-baseline SMPG data.
The LS means of the 7-point SMPG change from baseline to primary endpoint at week 28 was measured using a MMRM analysis adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline SMPG as covariate.
Outcome measures
| Measure |
Dulaglutide + Insulin Glargine
n=150 Participants
1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
Placebo + Insulin Glargine
n=150 Participants
Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
|---|---|---|
|
Change From Baseline to 28 Weeks in 7-Point Self Monitored Plasma Glucose (SMPG)
Pre-Morning Meal (n=133,129)
|
-44.03 mg/dL
Standard Error 2.71
|
-35.97 mg/dL
Standard Error 2.64
|
|
Change From Baseline to 28 Weeks in 7-Point Self Monitored Plasma Glucose (SMPG)
Morning Meal 2-Hour Postprandial (n=123,119)
|
-64.16 mg/dL
Standard Error 4.31
|
-46.97 mg/dL
Standard Error 4.27
|
|
Change From Baseline to 28 Weeks in 7-Point Self Monitored Plasma Glucose (SMPG)
Pre-Midday Meal (n=133,127)
|
-40.89 mg/dL
Standard Error 3.72
|
-25.34 mg/dL
Standard Error 3.62
|
|
Change From Baseline to 28 Weeks in 7-Point Self Monitored Plasma Glucose (SMPG)
Midday Meal 2-Hour Post Prandial (n=123,117)
|
-51.13 mg/dL
Standard Error 4.40
|
-32.98 mg/dL
Standard Error 4.33
|
|
Change From Baseline to 28 Weeks in 7-Point Self Monitored Plasma Glucose (SMPG)
Pre-Evening Meal (n=133,129)
|
-43.68 mg/dL
Standard Error 4.21
|
-28.71 mg/dL
Standard Error 4.07
|
|
Change From Baseline to 28 Weeks in 7-Point Self Monitored Plasma Glucose (SMPG)
Evening Meal 2-Hour Postprandial (n=126,122)
|
-48.63 mg/dL
Standard Error 5.22
|
-27.35 mg/dL
Standard Error 5.16
|
|
Change From Baseline to 28 Weeks in 7-Point Self Monitored Plasma Glucose (SMPG)
3:00 AM (Morning) (n=124,117)
|
-39.77 mg/dL
Standard Error 4.27
|
-20.30 mg/dL
Standard Error 4.23
|
SECONDARY outcome
Timeframe: Baseline, 28 WeeksPopulation: All participants who received at least one dose of study drug and had evaluable baseline and post-baseline body weight data.
LS means of the body weight change from baseline to primary endpoint at week 28 was adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline body weight as covariate, via a MMRM analysis.
Outcome measures
| Measure |
Dulaglutide + Insulin Glargine
n=150 Participants
1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
Placebo + Insulin Glargine
n=150 Participants
Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
|---|---|---|
|
Change From Baseline to 28 Weeks in Body Weight
|
-1.91 kilogram(kg)
Standard Error 0.30
|
0.50 kilogram(kg)
Standard Error 0.30
|
SECONDARY outcome
Timeframe: Baseline, 28 WeeksPopulation: All participants who one dose of study drug and had evaluable baseline and post-baseline insulin glargine data.
Least Square (LS) Means of the insulin dose change from baseline to primary endpoint at week 28 was adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline insulin dose as covariate, via a MMRM analysis.
Outcome measures
| Measure |
Dulaglutide + Insulin Glargine
n=150 Participants
1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
Placebo + Insulin Glargine
n=150 Participants
Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
|---|---|---|
|
Change From Baseline to 28 Weeks in Daily Mean Insulin Glargine Dose
|
12.75 units (u)
Standard Error 2.27
|
25.94 units (u)
Standard Error 2.30
|
SECONDARY outcome
Timeframe: Baseline through 28 WeeksPopulation: All randomized participants who received at least 1 dose of study.
Cardiovascular (CV) adverse events (AEs) were adjudicated by an independent committee of physicians with cardiology expertise external to the sponsor. Deaths occurring during the study treatment period and nonfatal CV AEs were to be adjudicated. Nonfatal CV events that were to be adjudicated were myocardial infarction; hospitalization for unstable angina; hospitalization for heart failure; coronary interventions (such as coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI); and cerebrovascular events, including cerebrovascular accident (CVA/stroke), and transient ischemic attack (TIA).
Outcome measures
| Measure |
Dulaglutide + Insulin Glargine
n=150 Participants
1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
Placebo + Insulin Glargine
n=150 Participants
Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
|---|---|---|
|
Number of Participants With Investigator Reported and Adjudicated Cardiovascular Events
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline through 28 WeeksPopulation: All randomized participants who received at least 1 dose of study drug.
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 percentage of participants with self-reported hypoglycemic events is presented.
Outcome measures
| Measure |
Dulaglutide + Insulin Glargine
n=150 Participants
1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
Placebo + Insulin Glargine
n=150 Participants
Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
|---|---|---|
|
Percentage of Participants With Self-Reported Events of Hypoglycemia
Symptomatic
|
35.3 percentage of participants
|
30.0 percentage of participants
|
|
Percentage of Participants With Self-Reported Events of Hypoglycemia
Asymptomatic
|
42.7 percentage of participants
|
39.3 percentage of participants
|
|
Percentage of Participants With Self-Reported Events of Hypoglycemia
Severe
|
0.7 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Self-Reported Events of Hypoglycemia
Nocturnal
|
28.0 percentage of participants
|
28.7 percentage of participants
|
|
Percentage of Participants With Self-Reported Events of Hypoglycemia
Probable Symptomatic
|
2.7 percentage of participants
|
2.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through 28 WeeksPopulation: All randomized participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Dulaglutide + Insulin Glargine
n=150 Participants
1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
Placebo + Insulin Glargine
n=150 Participants
Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
|---|---|---|
|
Percentage of Participants Discontinuing the Study Due to Severe, Persistent Hyperglycemia
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through 28 WeeksPopulation: All randomized participants who received at least 1 dose of study drug.
The number of cases of acute pancreatitis confirmed by adjudication. A summary of serious and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Dulaglutide + Insulin Glargine
n=150 Participants
1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
Placebo + Insulin Glargine
n=150 Participants
Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
|---|---|---|
|
Number of Participants With Adjudicated Acute Pancreatitis Events
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline through 28 WeeksPopulation: All randomized participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Dulaglutide + Insulin Glargine
n=150 Participants
1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
Placebo + Insulin Glargine
n=150 Participants
Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
|---|---|---|
|
Number of Participants With Thyroid Tumors/Neoplasms (Including C-Cell Hyperplasia)
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and Week 28Population: All randomized participants who received at least 1 dose of study drug and had at least one post-baseline Dulaglutide ADA test result.
Dulaglutide anti-drug antibodies (ADA) were assessed at baseline, Weeks 12 and 28. A participant was considered to have treatment-emergent (TE) dulaglutide ADAs if the participant had at least 1 titer that was TE relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.
Outcome measures
| Measure |
Dulaglutide + Insulin Glargine
n=149 Participants
1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
Placebo + Insulin Glargine
n=149 Participants
Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
|---|---|---|
|
Number of Participants With Dulaglutide Anti-Drug Antibodies
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 28 WeeksPopulation: All randomized participants who received at least 1 dose of study drug and had a baseline and post-baseline HbA1c data. Last observation carried forward (LOCF) methodology was used to impute missing post-baseline values.
Percentage of participants who achieved HbA1c levels of \<7% or ≤6.5% were analyzed using a logistic regression model, controlling for treatment, pre-treatment, baseline HbA1c and country.
Outcome measures
| Measure |
Dulaglutide + Insulin Glargine
n=150 Participants
1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
Placebo + Insulin Glargine
n=150 Participants
Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
|---|---|---|
|
Percentage of Participants Achieving HbA1c Targets of <7.0% or ≤6.5%
HbA1c <= 6.5
|
50.7 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants Achieving HbA1c Targets of <7.0% or ≤6.5%
HbA1c < 7.0
|
69.3 percentage of participants
|
35.3 percentage of participants
|
SECONDARY outcome
Timeframe: 28 WeeksPopulation: All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline HbA1c data.Last observation carried forward (LOCF) methodology was used to impute missing post-baseline values.
Percentage of participants who achieved a target HbA1c target of \<7%, without weight gain and without documented symptomatic hypoglycemia at 28 weeks were analyzed using regression model, controlling for treatment, pre-treatment, baseline HbA1c and country.
Outcome measures
| Measure |
Dulaglutide + Insulin Glargine
n=150 Participants
1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
Placebo + Insulin Glargine
n=150 Participants
Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
|---|---|---|
|
Percentage of Participants Achieving HbA1c Target of <7.0% and Without Weight Gain (<0.1 Kilograms [kg]) at 28 Weeks and Without Documented Symptomatic Hypoglycemia During the Maintenance Period (Weeks 12-28)
|
40.7 percentage of participants
|
16.7 percentage of participants
|
SECONDARY outcome
Timeframe: 28 WeeksPopulation: All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline HbA1c data. Last observation carried forward (LOCF) methodology was used to impute missing post-baseline values
Percentage of participants achieving target HbA1c of \<7.0% at 28 weeks without documented symptomatic hypoglycemia are presented. Documented symptomatic hypoglycemia is defined as any time a participant experienced symptoms and or signs associated with hypoglycemia and had a plasma glucose of \<=70 mg/dL.
Outcome measures
| Measure |
Dulaglutide + Insulin Glargine
n=150 Participants
1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
Placebo + Insulin Glargine
n=150 Participants
Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
|---|---|---|
|
Percentage of Participants Achieving HbA1c Target of <7.0% at 28 Weeks and Without Documented Symptomatic Hypoglycemia During the Maintenance Period (Weeks 12-28)
|
52.0 percentage of participants
|
28.0 percentage of participants
|
SECONDARY outcome
Timeframe: 28 WeeksPopulation: All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline HbA1c data. Last observation carried forward (LOCF) methodology was used to impute missing post-baseline values.
Outcome measures
| Measure |
Dulaglutide + Insulin Glargine
n=150 Participants
1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
Placebo + Insulin Glargine
n=150 Participants
Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
|---|---|---|
|
Percentage of Participants Achieving HbA1c Target of <7.0% and Without Weight Gain (<0.1 kg)
|
52.7 percentage of participants
|
20.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through 28 WeeksPopulation: All randomized participants who received at least 1 dose of study drug.
The rate of total hypoglycemic events any type per 30 days is presented. The hypoglycemia rate per 30 days during defined period is calculated by the number of hypoglycemia events within the period/number of days participant at risk within the period\*30 days.
Outcome measures
| Measure |
Dulaglutide + Insulin Glargine
n=150 Participants
1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
Placebo + Insulin Glargine
n=150 Participants
Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
|---|---|---|
|
Rate of Hypoglycemic Events up to 28 Weeks
|
0.63 rate of hypoglycemic events per 30 days
Standard Deviation 1.24
|
0.70 rate of hypoglycemic events per 30 days
Standard Deviation 1.32
|
Adverse Events
Dulaglutide + Insulin Glargine
Placebo + Insulin Glargine
Serious adverse events
| Measure |
Dulaglutide + Insulin Glargine
n=150 participants at risk
1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
Placebo + Insulin Glargine
n=150 participants at risk
Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.67%
1/150 • Number of events 1
|
0.67%
1/150 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.67%
1/150 • Number of events 1
|
0.00%
0/150
|
|
Cardiac disorders
Bradycardia
|
1.3%
2/150 • Number of events 2
|
0.00%
0/150
|
|
Cardiac disorders
Coronary artery disease
|
0.67%
1/150 • Number of events 1
|
0.00%
0/150
|
|
Cardiac disorders
Myocardial infarction
|
0.67%
1/150 • Number of events 1
|
0.00%
0/150
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/150
|
0.67%
1/150 • Number of events 1
|
|
Hepatobiliary disorders
Granulomatous liver disease
|
0.67%
1/150 • Number of events 1
|
0.00%
0/150
|
|
Infections and infestations
Gastroenteritis
|
0.67%
1/150 • Number of events 1
|
0.00%
0/150
|
|
Infections and infestations
Viral infection
|
0.00%
0/150
|
0.67%
1/150 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.67%
1/150 • Number of events 1
|
0.00%
0/150
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.67%
1/150 • Number of events 1
|
0.00%
0/150
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/150
|
0.67%
1/150 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/150
|
0.67%
1/150 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/150
|
0.67%
1/150 • Number of events 1
|
|
Nervous system disorders
Carotid artery stenosis
|
0.67%
1/150 • Number of events 1
|
0.00%
0/150
|
|
Nervous system disorders
Cerebral infarction
|
0.67%
1/150 • Number of events 1
|
0.00%
0/150
|
|
Nervous system disorders
Transient ischaemic attack
|
1.3%
2/150 • Number of events 2
|
0.00%
0/150
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/150
|
0.67%
1/150 • Number of events 1
|
Other adverse events
| Measure |
Dulaglutide + Insulin Glargine
n=150 participants at risk
1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Dulaglutide: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
Placebo + Insulin Glargine
n=150 participants at risk
Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
Placebo: Administered SQ
Insulin Glargine: Administered SQ
Metformin: Administered orally
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
11.3%
17/150 • Number of events 19
|
4.0%
6/150 • Number of events 6
|
|
Gastrointestinal disorders
Dyspepsia
|
6.0%
9/150 • Number of events 9
|
0.00%
0/150
|
|
Gastrointestinal disorders
Nausea
|
12.0%
18/150 • Number of events 23
|
1.3%
2/150 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
9/150 • Number of events 11
|
0.00%
0/150
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
6/150 • Number of events 7
|
9.3%
14/150 • Number of events 19
|
|
Infections and infestations
Upper respiratory tract infection
|
7.3%
11/150 • Number of events 18
|
6.7%
10/150 • Number of events 10
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.7%
10/150 • Number of events 11
|
0.00%
0/150
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60