A Phase 3 interventional study of Dulaglutide in Diabetes Mellitus, Type 2, sponsored by Eli Lilly and Company. Completed at 208 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-12.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of investigational doses of once weekly dulaglutide when added to metformin in participants with type 2 diabetes with inadequate blood sugar control.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 1,842 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.
Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.
Drug: Dulaglutide
Dulaglutide 3 mg administered SC once a week.
Drug: Dulaglutide
Dulaglutide 4.5 mg administered SC once a week.
Drug: Dulaglutide
Administered SC
Also known as: LY2189265
Change in Hemoglobin A1c (HbA1c) From Baseline
HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables:Baseline + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares).
Time frame: Baseline, Week 36
Change in Body Weight From Baseline
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with independent variables: Baseline + Baseline HbA1c group + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares).
Time frame: Baseline, Week 36
Percentage of Participants Achieving HbA1c Target <7.0%
Percentage of participants achieving HbA1c target \<7.0%.
Time frame: Week 36
Change in Fasting Serum Glucose (FSG) From Baseline
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Baseline HbA1c group + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares).
Time frame: Baseline, Week 36
Rate of Documented Symptomatic Hypoglycemic Episodes
Hypoglycemia was defined as blood glucose \< 54 mg/dL, excluding post-rescue records. Estimate is based on Group Mean from negative binomial model. The negative binomial model for post-baseline comparisons between treatments and control group: Number of episodes = Pooled Country + HbA1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.
Time frame: Week 36
Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss)
Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss).
Time frame: Week 4, Week 12, Week 36, Week 52
Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State
Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State.
Time frame: Week 4, Week 12, Week 36, Week 52
| Milestone | Dulaglutide 1.5 mg | Dulaglutide 3 mg | Dulaglutide 4.5 mg |
|---|---|---|---|
| Started | 612 | 616 | 614 |
| Received at least one dose of study drug | 612 | 616 | 614 |
| Completed | 556 | 549 | 560 |
| Not completed | 56 | 67 | 54 |
| Withdrew: Adverse event | 5 | 7 | 10 |
| Withdrew: Death | 3 | 4 | 4 |
| Withdrew: Lost to follow-up | 15 | 16 | 17 |
| Withdrew: Physician decision | 2 | 0 | 2 |
| Withdrew: Withdrawal by subject | 25 | 36 | 18 |
| Withdrew: Protocol violation | 1 | 1 | 0 |
| Withdrew: Site closure | 3 | 1 | 2 |
| Withdrew: Non-compliance | 1 | 0 | 0 |
| Withdrew: Participant duplicated at another site | 0 | 0 | 1 |
| Withdrew: Primary care physician recommendation | 0 | 1 | 0 |
| Withdrew: Relocated to another country | 0 | 1 | 0 |
| Withdrew: Participant was in rehabilitation | 1 | 0 | 0 |
HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables:Baseline + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares).
| Percentage of HbA1c | Dulaglutide 1.5 mg | Dulaglutide 3 mg | Dulaglutide 4.5 mg |
|---|---|---|---|
| Change in Hemoglobin A1c (HbA1c) From Baseline | -1.53 ± 0.04 | -1.71 ± 0.04 | -1.87 ± 0.04 |
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with independent variables: Baseline + Baseline HbA1c group + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares).
| Kilograms (Kg) | Dulaglutide 1.5 mg | Dulaglutide 3 mg | Dulaglutide 4.5 mg |
|---|---|---|---|
| Change in Body Weight From Baseline | -3.1 ± 0.19 | -4.0 ± 0.19 | -4.7 ± 0.19 |
Percentage of participants achieving HbA1c target \<7.0%.
| percentage of participants | Dulaglutide 1.5 mg | Dulaglutide 3 mg | Dulaglutide 4.5 mg |
|---|---|---|---|
| Percentage of Participants Achieving HbA1c Target <7.0% | 56.98 | 64.68 | 71.48 |
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Baseline HbA1c group + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares).
| milligrams per deciliter (mg/dL) | Dulaglutide 1.5 mg | Dulaglutide 3 mg | Dulaglutide 4.5 mg |
|---|---|---|---|
| Change in Fasting Serum Glucose (FSG) From Baseline | -44.2 ± 1.50 | -47.9 ± 1.50 | -52.3 ± 1.50 |
Hypoglycemia was defined as blood glucose \< 54 mg/dL, excluding post-rescue records. Estimate is based on Group Mean from negative binomial model. The negative binomial model for post-baseline comparisons between treatments and control group: Number of episodes = Pooled Country + HbA1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.
| Episodes/participant/365.25 days | Dulaglutide 1.5 mg | Dulaglutide 3 mg | Dulaglutide 4.5 mg |
|---|---|---|---|
| Rate of Documented Symptomatic Hypoglycemic Episodes | 0.02 ± 0.01 | 0.00 ± 0.00 | 0.02 ± 0.01 |
Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss).
| nanogram/milliliter (ng/mL) | Dulaglutide 1.5 mg | Dulaglutide 3 mg | Dulaglutide 4.5 mg |
|---|---|---|---|
| Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss) | 79.6 (77.7 to 81.7) | 159 (155 to 163) | 238 (232 to 243) |
Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State.
| nanogram*hour/milliliter (ng*h/mL) | Dulaglutide 1.5 mg | Dulaglutide 3 mg | Dulaglutide 4.5 mg |
|---|---|---|---|
| Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State | 11200 (10900 to 11500) | 22300 (21800 to 22900) | 33400 (32700 to 34200) |
Collected over Up to Week 56. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dulaglutide 1.5 mg | 3/612 (0.5%) | 53/612 (8.7%) | 156/612 (25.5%) |
| Dulaglutide 3 mg | 4/616 (0.6%) | 45/616 (7.3%) | 190/616 (30.8%) |
| Dulaglutide 4.5 mg | 4/614 (0.7%) | 38/614 (6.2%) | 195/614 (31.8%) |
| Event | Dulaglutide 1.5 mg | Dulaglutide 3 mg | Dulaglutide 4.5 mg |
|---|---|---|---|
| PregnancyPregnancy, puerperium and perinatal conditions | 0/314 | 2/288 | 0/296 |
| Atrial fibrillationCardiac disorders | 3/612 | 0/616 | 1/614 |
| Cervical polypReproductive system and breast disorders | 0/314 | 1/288 | 0/296 |
| Ovarian cystReproductive system and breast disorders | 0/314 | 0/288 | 1/296 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/298 | 0/328 | 0/318 |
| Acute myocardial infarctionCardiac disorders | 2/612 | 2/616 | 0/614 |
| Non-cardiac chest painGeneral disorders | 2/612 | 1/616 | 1/614 |
| PneumoniaInfections and infestations | 2/612 | 2/616 | 1/614 |
| Lipase increasedInvestigations | 2/612 | 0/616 | 1/614 |
| Abdominal painGastrointestinal disorders | 1/612 | 0/616 | 2/614 |
| Event | Dulaglutide 1.5 mg | Dulaglutide 3 mg | Dulaglutide 4.5 mg |
|---|---|---|---|
| NauseaGastrointestinal disorders | 87/612 | 99/616 | 106/614 |
| DiarrhoeaGastrointestinal disorders | 48/612 | 75/616 | 70/614 |
| VomitingGastrointestinal disorders | 40/612 | 57/616 | 64/614 |
| NasopharyngitisInfections and infestations | 29/612 | 33/616 | 39/614 |
| DyspepsiaGastrointestinal disorders | 17/612 | 33/616 | 18/614 |
All participants who received at least one dose of study drug.
| Age, Continuous(years) | Dulaglutide 1.5 mg | Dulaglutide 3 mg | Dulaglutide 4.5 mg | Total |
|---|---|---|---|---|
| Mean | 57.8 ± 9.7 | 56.9 ± 10.2 | 56.6 ± 10.2 | 57.1 ± 10.0 |
| Sex: Female, Male(Participants) | Dulaglutide 1.5 mg | Dulaglutide 3 mg | Dulaglutide 4.5 mg | Total |
|---|---|---|---|---|
| Female | 314 | 288 | 296 | 898 |
| Male | 298 | 328 | 318 | 944 |
| Ethnicity (NIH/OMB)(Participants) | Dulaglutide 1.5 mg | Dulaglutide 3 mg | Dulaglutide 4.5 mg | Total |
|---|---|---|---|---|
| Hispanic or Latino | 214 | 214 | 213 | 641 |
| Not Hispanic or Latino | 369 | 363 | 371 | 1103 |
| Unknown or Not Reported | 29 | 39 | 30 | 98 |
| Race (NIH/OMB)(Participants) | Dulaglutide 1.5 mg | Dulaglutide 3 mg | Dulaglutide 4.5 mg | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 30 | 26 | 32 | 88 |
| Asian | 13 | 18 | 14 | 45 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 3 | 5 |
| Black or African American | 28 | 31 | 23 | 82 |
| White | 529 | 521 | 530 | 1580 |
| More than one race | 11 | 19 | 12 | 42 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Dulaglutide 1.5 mg | Dulaglutide 3 mg | Dulaglutide 4.5 mg | Total |
|---|---|---|---|---|
| Argentina | 96 | 97 | 97 | 290 |
| Romania | 77 | 78 | 78 | 233 |
| Hungary | 25 | 24 | 24 | 73 |
| United States | 169 | 169 | 170 | 508 |
| Russia | 9 | 10 | 10 | 29 |
| Spain | 19 | 20 | 19 | 58 |
| Greece | 33 | 34 | 33 | 100 |
| Canada | 12 | 11 | 12 | 35 |
| Austria | 4 | 4 | 5 | 13 |
| Taiwan | 5 | 5 | 5 | 15 |
| Poland | 56 | 56 | 55 | 167 |
| Mexico | 37 | 38 | 36 | 111 |
| Italy | 9 | 8 | 8 | 25 |
| Slovakia | 43 | 44 | 44 | 131 |
| Israel | 18 | 18 | 18 | 54 |
| Hemoglobin A1C (HbA1c) at Baseline(Percentage of HbA1c) | Dulaglutide 1.5 mg | Dulaglutide 3 mg | Dulaglutide 4.5 mg | Total |
|---|---|---|---|---|
| Mean | 8.64 ± 0.94 | 8.63 ± 1.00 | 8.64 ± 0.91 | 8.64 ± 0.95 |
Showing the first 100 of 208 sites across 16 countries.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · vivli.org
Ran from Apr 2018 to primary completion in May 2019, 13 months.
Results were first posted in Jun 2020, 1 year after primary completion.
Of 430 industry-sponsored phase 3 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 26. This study's 13 months is below that.
Counting every sponsor, half of 510 studies reached it within 20 months; a quarter within 14 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dulaglutide