Phase 1
Completed N=12
Evaluation of the Glucoregulatory Effects of Glucagon-like Peptide-1 Receptor (GLP-1 Receptor) Activation in Participants With Type 2 Diabetes Mellitus (MK-0000-222)
Source: ClinicalTrials.gov NCT01373450 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcomePrimary: Change From Baseline in Time-weighted Average of Glucose Measured by Area Under the Curve (AUC) After a Single Dose of Oxyntomodulin (OXM) — 106.3; 122.6 mg/dL — p=0.024
Summary
This was a four-period crossover study to assess the glycemic effects of a single dose of oxyntomodulin (OXM) on the glucose levels in participants with Type 2 diabetes mellitus (T2DM). Participants were randomly assigned to 1 of 6 treatment sequences consisting of 4 treatment periods, with a 7-day wash-out between each treatment period. The primary hypothesis was that during graded glucose infusion (GGI) oxyntomodulin (OXM) is neutral or better than placebo (Pbo) at lowering ambient plasma glucose levels, and at significantly enhancing insulin secretion.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Time-weighted Average of Glucose Measured by Area Under the Curve (AUC) After a Single Dose of Oxyntomodulin (OXM) |
106.3; 122.6 | 0.024 sig |
| PRIMARY Change From Baseline in Maximum Ambient Glucose Concentration (Gmax) After a Single Dose of OXM |
211.0; 272.9 | 0.004 sig |
| PRIMARY Change From Baseline in Beta Cell Sensitivity to Glucose (Φ) After a Single Dose of OXM |
0.019; 0.006 | <0.001 sig |
| SECONDARY Change From Baseline in Insulinotrophic Effect (ISR/G) at the Highest Glucose Infusion Rate After Two Periods of Placebo Treatment |
0.0075; 0.0070 | — |
| SECONDARY Change From Baseline in Gmax After Single Doses of 0.6 mg Lg, or 1.2 mg Lg, Compared With Single Doses of Placebo or OXM |
209.7; 157.9; 211.0; 272.9 | 0.003 sig |
| SECONDARY Change From Baseline in Insulinotrophic Effect (ISR/G) After Single Doses of 0.6 mg Lg, or 1.2 mg Lg, Compared With Single Doses of Placebo or OXM |
0.026; 0.035; 0.019; 0.006 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Have a body mass index (BMI) of ≤38.0 kg/m^2
- Have a clinical diagnosis of Type 2 diabetes mellitus
- Have a glycated hemoglobin (HbA1C) at screening ≤9.0%; fasting plasma glucose should not exceed 300 mg/dL (16.8 mmol/L)
- Judged to be in good health
Exclusion Criteria
- Have a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study
- Have a history of stroke, chronic seizures, major neurological disorder, clinically significant endocrine, cardiovascular, hematological, hepatic, renal, respiratory, or genitourinary abnormalities or diseases
- Have untreated hypertension with blood pressure of >160/95 mmHg
- Have a history of neoplastic disease within the past 5 years
- Have a history of hypersensitivity to OXM, liraglutide, insulin or Haemaccel®
- Unable or unwilling to comply with restrictions around concomitant medications
- Consume excessive amounts of alcohol, coffee, tea, cola, or other caffeinated beverages daily
- Have had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks
- Have a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
- Currently a regular user (including use of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 3 months
- Are unwilling or unable to consume the standardized meals during the study and/or is on a carbohydrate restricted diet (i.e., a diet <100 grams per day of carbohydrate)
Data sourced from ClinicalTrials.gov (NCT01373450). 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.