Phase 3
Completed N=577
A Study Comparing Dulaglutide With Insulin Glargine on Glycemic Control in Participants With Type 2 Diabetes (T2D) and Moderate or Severe Chronic Kidney Disease (CKD)
Source: ClinicalTrials.gov NCT01621178 ↗Enrolled (actual)
577
Serious AEs
25.2%
Results posted
Jul 2017
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) — -1.13; -1.12; -1.19 percentage of HbA1c — p=<0.001
Summary
The purpose of this study is to determine the glycemic efficacy and safety of dulaglutide compared to insulin glargine in the treatment of participants with type 2 diabetes and moderate or severe chronic kidney disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HbA1c) |
-1.13; -1.12; -1.19 | <0.001 sig |
| SECONDARY Percentage of Participants Whose HbA1c Was <7.0% |
34.6; 31.7; 37.5 | — |
| SECONDARY Percentage of Participants Whose HbA1c Was <8.0% |
75.3; 72.6; 78.3 | — |
| SECONDARY Change From Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG) |
-37.6; -31.7; -33.7 | — |
| SECONDARY Change From Baseline in Fasting Glucose (FG) |
-19.1; 17.7; 23.1 | — |
| SECONDARY Change From Baseline in Mean Daily Insulin Lispro Dose |
16.64; 26.16; 18.12 | — |
| SECONDARY Percentage of Participants With Estimated Average Glucose <154 mg/dL |
73.7; 57.4; 50.9 | — |
| SECONDARY Change From Baseline in Serum Creatinine (sCr) |
0.10; 0.02; 0.04 | — |
| SECONDARY Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) |
-2.5; -1.0; -1.0 | — |
| SECONDARY Change From Baseline in Estimated Creatinine Clearance (eCrCl) |
-2.0; -1.0; -0.5 | — |
| SECONDARY Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR) |
-1.3; -11.1; -10.2 | — |
| SECONDARY Change From Baseline in Body Weight |
1.57; -1.71; -2.66 | — |
| SECONDARY Percentage of Participants With Self-Reported Hypoglycemic Events (HE) |
74.7; 59.8; 50.0; 63.4; 48.1; 40.5 | — |
| SECONDARY Rate of Hypoglycemic Events |
17.07; 7.76; 5.45; 11.34; 4.86; 4.19 | — |
| SECONDARY Change From Baseline in HbA1c |
-1.00; -1.10; -1.10 | — |
| SECONDARY Percentage of Participants Whose HbA1c is <7.0% |
29.1; 33.5; 32.9 | — |
| SECONDARY Percentage of Participants Whose HbA1c is <8.0% |
70.3; 69.5; 69.1 | — |
| SECONDARY Change From Baseline in 8-Point SMPG |
-40.5; -30.0; -27.2 | — |
| SECONDARY Change From Baseline in FG |
-6.4; 20.8; 28.3 | — |
| SECONDARY Change in Mean Daily Insulin Lispro Dose |
16.84; 27.46; 20.05 | — |
| SECONDARY Percentage of Participants With Estimated Average Glucose <154 mg/dL |
73.7; 57.4; 50.9 | — |
| SECONDARY Change From Baseline in sCr |
0.12; 0.04; 0.07 | — |
| SECONDARY Change From Baseline in eGFR |
-3.3; -1.5; -2.0 | — |
| SECONDARY Change From Baseline in eCrCl |
-2.5; -1.3; -1.5 | — |
| SECONDARY Change From Baseline in UACR |
3.5; -3.0; -11.5 | — |
| SECONDARY Change From Baseline in Body Weight |
1.57; -1.71; -2.66 | — |
| SECONDARY Percentage of Participants With Self-Reported Hypoglycemic Events (HE) |
74.7; 59.8; 50.0; 63.4; 48.1; 40.5 | — |
| SECONDARY Rate of Hypoglycemic Events (HE) |
14.36; 7.59; 5.82; 9.62; 4.34; 4.44 | — |
| SECONDARY Participants With Events of Allergic/Hypersensitivity Reactions |
1; 2; 2; 0; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Men and non-pregnant women aged ≥18 years
- Hemoglobin A1c (HbA1c) ≥7.5% and ≤10.5%
- Type 2 diabetes on insulin or insulin + oral antihyperglycemic medication
- Participants with presumed diabetic kidney disease with or without hypertensive nephrosclerosis diagnosed with moderate or severe CKD with estimated glomerular filtration rate (eGFR) of ≥15 to <60 milliliters per minute (mL/min)/1.73 meter squared (m^2)
- Able and willing to perform multiple daily injections
- Body mass index (BMI) between 23 and 45 kilogram/square meter (kg/m^2)
Exclusion Criteria
- Stage 5 CKD as defined by eGFR <15 mL/min/1.73 m^2 OR having required dialysis
- Rapidly progressing renal dysfunction likely to require renal replacement
- History of a transplanted organ
- Type 1 diabetes mellitus
- At screening a systolic blood pressure of ≥150 mmHg or a diastolic blood pressure of ≥90 mmHg with or without antihypertensive medication
- An episode of ketoacidosis or hyperosmolar state/coma in the past 6 months or a history of severe hypoglycemia in the past 3 months prior to the Screening Visit
- Cardiovascular conditions within 12 weeks prior to randomization: acute myocardial infarction, New York Heart Association (NYHA) class III or class IV heart failure, or cerebrovascular accident (stroke)
- Acute or chronic hepatitis
- Signs and symptoms of chronic or acute pancreatitis, or were in the past diagnosed with pancreatitis
- Serum calcitonin ≥35 picograms per milliliter (pg/mL) at Screening Visit
- Self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma
- Known history of untreated proliferative retinopathy
Data sourced from ClinicalTrials.gov (NCT01621178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.