Use of Continuous Glucose Monitoring Combined With Ambulatory Glucose Profiles to Characterize Glycemic Control

This study has been completed.
Sponsor:
Collaborator:
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
Park Nicollet Institute
ClinicalTrials.gov Identifier:
NCT00806520
First received: December 8, 2008
Last updated: August 30, 2011
Last verified: August 2011
  Purpose

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.


Condition
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by Park Nicollet Institute:

Enrollment: 16
Study Start Date: April 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants in the Amylin BCB106 Protocol Main Study

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806520

Locations
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
United States, Minnesota
International Diabetes Center
Minneapolis, Minnesota, United States, 55416
United States, Nevada
Palm Medical Group
Las Vegas, Nevada, United States, 89148
United States, North Carolina
University of North Carolina Diabetes Care Center
Durham, North Carolina, United States, 27713
United States, Washington
Rockwood Clinic
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Park Nicollet Institute
Amylin Pharmaceuticals, LLC.
Investigators
Principal Investigator: Richard M. Bergenstal, MD International Diabetes Center at Park Nicollet
Principal Investigator: Roger S. Mazze, PhD International Diabetes Center at Park Nicollet
Principal Investigator: Robert M. Cuddihy, MD International Diabetes Center at Park Nicollet
Principal Investigator: Elinor (Ellie) S. Strock, APRN, BS,CDE International Diabetes Center at Park Nicollet
  More Information

No publications provided

Responsible Party: Park Nicollet Institute
ClinicalTrials.gov Identifier: NCT00806520     History of Changes
Other Study ID Numbers: 03671-08-C
Study First Received: December 8, 2008
Last Updated: August 30, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Park Nicollet Institute:
Continuous Glucose Monitoring
Exenatide Once Weekly or
Januvia or
Actos

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 22, 2014