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OpenTrials
Completed

NCT Number: NCT00806520

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Joslin Diabetes Center, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

  • Amylin Pharmaceuticals, LLC.

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Dec 10, 2008
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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