Outpatient Characterization of the Variability of Insulin Secretory Parameters in the Meal Tolerance and the Maximal Stimulation Tests of Subjects With Type 2 Diabetes Mellitus

NCT02346344 | Completed

• 1 other identifier: Beta Cell - Protocol 1e
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

A multi-year clinical study to improve tools for measuring the function of insulin-producing beta cells in people with type 2 diabetes mellitus.

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes; beta cell function; meal tolerance test; maximum stimulation test; method standardization; insulin secretion; prediabetes; insulin sensitivity

Outcome Measures

Primary Outcomes (1)

• Repeatability of the meal tolerance test and the arginine stimulation test, as indicated by the ICC (intraclass correlation coefficient)

  Up to 28 days

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

obese individuals with type 2 diabetes mellitus

You may qualify if:

• Ability to give informed consent and comply with all study requirements
• Overweight and obese men and women. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history (with the exception of glucose, see below), full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.
• T2D diagnosis by ADA criteria 2011
• Glucose Parameters:
• Fasting glucose 126-270 mg/dL
• HbA1c 6.5%--10.0%
• Diabetes medications allowed: metformin only: stable dose (8 weeks or longer) and 500-2000 mg/day;
• Estimated creatinine clearance, by Cockcroft-Gault, \>60 cc/min
• No washout of medications allowed
• Women of child-bearing potential are allowed (but must agree to use non-hormonal contraception and not plan to become pregnant for the duration of the study). Must agree to maintain the same contraceptive measures throughout the study. Acceptable contraceptive methods for female subjects of childbearing potential include one of the following:
• Abstinence.
• One (1) of the following methods:
• Tubal ligation
• Copper-containing intrauterine device (IUD)
• Condom AND spermicidal foam/gel/film/cream/suppository

You may not qualify if:

• Subjects presenting with any of the following will not be included in the study:
• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, neoplastic, or allergic or clinical findings at Screening (seasonal allergies allowed).
• Any condition possibly affecting absorption (eg, gastrectomy, malabsorption syndromes, abdominal surgery other than appendectomy, cholecystectomy or hysterectomy).
• Use of unacceptable medications (see Appendix A)
• A positive urine drug screen.
• History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
• Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication.
• lead ECG demonstrating QTc \>450 msec at Screening for males, 470 msec for females. If QTc exceeds 450/470 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility. An ECG with evidence for possible old myocardial infarction will need to have prior ECGs to document stability of finding.
• Supine blood pressure \>=140 mm Hg (systolic) or 90 mm Hg (diastolic), on a single measurement. If elevated, confirm by a single repeat, following at least 10 minutes of rest.
• Screening serum alanine transaminase (ALT) or serum aspartate transaminase (AST) greater than 2X the upper limit of the laboratory reference range.
• Elevated fasting triglycerides at screening (\>500 mg/dL), confirmed by a single repeat if deemed necessary.
• Pregnant or nursing females; inability to use effective contraception.
• Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
• Participation in a clinical biomedical research study within prior two months may be excluded, depending on study type and details.
• History of sensitivity to heparin or heparin-induced thrombocytopenia, if utilized by the site for blood draws.

Sponsors & Collaborators

• Foundation for the National Institutes of Health: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Juvenile Diabetes Research Foundation: collaborator
• Amylin Pharmaceuticals, LLC.: collaborator
• Merck Sharp & Dohme LLC: collaborator
• Pfizer: collaborator
• Eli Lilly and Company: collaborator
• Takeda: collaborator
• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: collaborator
• Novartis: collaborator

Study Sites (2)

Celerion

Tempe, Arizona, 85283, United States

Location

ICON Development Solutions, Gault Lane

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Prediabetic State; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Dennis Ruff, MD

  ICON Development Solutions

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: January 27, 2015
• Study Start: April 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 27, 2015

Record last verified: 2015-01

Locations

US (2)