Clinical trial NCT00806520: Use of Continuous Glucose Monitoring Combined With Ambulatory Glucose Profiles to Characterize Glycemic Control
Official title: Use of Continuous Glucose Monitoring Combined With Ambulatory Glucose Profiles to Characterize Glycemic Control Addendum to: A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Long-Acting Release to Those of Sitagliptin and Pioglitazone in Subjects With Type 2 Diabetes Mellitus Treated With Metformin (Study BCB106)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: Continuous Glucose Monitoring
Exenatide Once Weekly or
Januvia or
Actos
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: Amylin Pharmaceuticals, LLC.
First posted: 2008-12-10
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in the Amylin BCB106 Protocol Main Study

Brief summary: Obtain Continuous Glucose Monitoring (CGM) data from individuals taking exenatide LAR, sitagliptin, or pioglitazone. The CGM measurements collected will help determine the characteristics of glucose control prior to treatment and during treatment.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* type 2 diabetes
* A1c 7.1 - 11
* BMI 25 - 45
* stable weight for 3 months before screening
* fasting glucose \< 280 at screening
* stable dose of metformin for at least 2 months before screening
* not being treated with or on a stable dose of hormone replacement therapy, oral contraceptives, anti-hypertensive agents, lipid lowering agents, thyroid replacement therapy, anti-depressants, drugs known to affect body weight
* male or female, non-lactating, non-pregnant and willing to use birth control
* lab values that are not clinically significant at screening
* physical exam and ECG that are not clinically significant at screening
* able to read, understand, and sign consent form

Exclusion Criteria:

* liver disease
* renal disease
* cardiovascular disease
* gastroparesis
* cancer within 5 years of screening
* macular edema
* chronic infections
* drug or alcohol abuse
* fasting triglycerides \> or = 600 at screening
* previous exposure to exenatide LAR
* has donated blood within 60 days of screening or is planning to donate during the study
* has had a major surgery or blood transfusion within 2 months before screening
* is currently being treated or is expecting to be treated with Byetta, Januvia, SU, TZD, GLP-1 analog, alpha-glucosidase inhibitor, meglitinide, nateglinide, symlin, insulin, systemic corticosteroids, lopid or rifampin
* has received an investigational drug within 1 month before screening
* has allergies or hypersensitivity to any component of the study drug
* has previously had an adverse event related to TZD or Januvia
* is an immediate family member of the study sight or directly affiliated
* is employed by Amylin, Lilly or Alkermes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Minneapolis
country: United States
facility: International Diabetes Center
state: Minnesota
city: Las Vegas
country: United States
facility: Palm Medical Group
state: Nevada
city: Durham
country: United States
facility: University of North Carolina Diabetes Care Center
state: North Carolina
city: Spokane
country: United States
facility: Rockwood Clinic
state: Washington
Study officials:
affiliation: International Diabetes Center at Park Nicollet
name: Richard M. Bergenstal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Diabetes Center at Park Nicollet
name: Roger S. Mazze, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Diabetes Center at Park Nicollet
name: Robert M. Cuddihy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Diabetes Center at Park Nicollet
name: Elinor (Ellie) S. Strock, APRN, BS,CDE
role: PRINCIPAL_INVESTIGATOR
References: