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)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Oxyntomodulin; Liraglutide 0.6 mg; Liraglutide 1.2 mg; Placebo for Oxyntomodulin; Placebo for Liraglutide
Intervention description: 3.0 pmol/kg/min as an intravenous (IV) infusion in the morning of the day of graded glucose infusion (GGI) (Day 1); Single subcutaneous dose in the evening of the day before the GGI (Day-1); Single subcutaneous dose in the evening of the day before the GGI (Day-1); IV infusion in the morning of the day of GGI (Day 1); Single subcutaneous dose in the evening of the day before the GGI (Day-1)
Intervention MeSH terms: Liraglutide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 12.0
Sex: Male
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

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.
    

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)