Phase 2
Completed N=89
A Study of Multiple Oral Doses of JNJ-41443532 in Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01230749 ↗Enrolled (actual)
89
Serious AEs
1.1%
Results posted
Dec 2013
Primary outcomePrimary: Change From Baseline (Day -1) to Day 28 in Twenty-Four-Hour Weighted Average Glucose (24-Hour WAG) — -18.88; -11.95; -4.72; 8.52 mg/dL — p=0.006
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what the body does to the medication) and pharmacodynamics (what the medication does to the body) of treatment with JNJ-41443532 relative to treatment with placebo in type 2 diabetes mellitus participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (Day -1) to Day 28 in Twenty-Four-Hour Weighted Average Glucose (24-Hour WAG) |
-18.88; -11.95; -4.72; 8.52 | 0.006 sig |
| SECONDARY Change From Baseline to Day 28 in Fasting Plasma Glucose (FPG) |
-14.57; -8.26; -4.00; 13.71 | 0.005 sig |
| SECONDARY Change From Baseline to Day 28 in Insulin Secretion |
-4.00; 6.94; -0.89; -6.76 | 0.628 |
| SECONDARY Change From Baseline to Day 28 in Insulin Resistance |
-1.52; 0.07; -0.35; 0.33 | 0.041 sig |
| SECONDARY Change From Baseline to Day 28 in Systemic Levels of Interleukin 6 (IL-6) |
0.86; 0.81; 0.91 | 0.774 |
| SECONDARY Change From Baseline to Day 28 in Systemic Levels of Interleukin 18 (IL-18) |
1.02; 1.03; 1.02 | 0.968 |
| SECONDARY Change From Baseline to Day 28 in Systemic Levels of C-Reactive Protein (CRP) |
1.12; 0.86; 0.84 | 0.097 |
| SECONDARY Change From Baseline to Day 29 in Body Weight |
-0.75; -1.18; -0.19; -1.21 | 0.295 |
Eligibility Criteria
Inclusion Criteria
- Diagnosed Type 2 Diabetes Mellitus (T2DM) for at least 3 months prior screening
- On a stable treatment regimen for at least 2 months prior screening
- Medically stable on the basis of physical examination, medical history, and clinical laboratory tests performed at screening and 2 days before administration of the study medication
- Fasting plasma glucose (FPG) concentrations between 140 mg/dL and 270 mg/dL on 2 days before administration of the study medication
- Agrees to protocol-defined use of effective contraception
Exclusion Criteria
- History of other types of diabetes and complications or secondary forms of diabetes
- History of eating disorder or recent significant changes in body weight (ie, more or equal to 5 percent over 3 months prior to screening) due to dieting or nutritional treatments
- Taking antihyperglycemic agents (insulin, exenatide, and liraglutide) within 6 months or thiazolidinedione within 3 months of 2 days before administration of the study medication
- Clinically significant abnormal electrocardiogram
- History of, or currently active, significant illness or medical disorders, retinal disease, tuberculosis
- Clinically important serious infection, positive for serology at screening (hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus antibodies)
Data sourced from ClinicalTrials.gov (NCT01230749). 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.