Use of Continuous Glucose Monitoring Combined With Ambulatory Glucose Profiles to Characterize Glycemic Control
This study has been completed.
Sponsor:
Park Nicollet Institute
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
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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:
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
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 Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013