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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 8, 2008

Last Updated Date

August 30, 2011

Start Date ^ICMJE

April 2008

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00806520 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Participants in the Amylin BCB106 Protocol Main Study

Condition ^ICMJE

Type 2 Diabetes

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2011

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00806520

Other Study ID Numbers ^ICMJE

03671-08-C

Has Data Monitoring Committee

Responsible Party

Park Nicollet Institute

Study Sponsor ^ICMJE

Park Nicollet Institute

Collaborators ^ICMJE

Amylin Pharmaceuticals, LLC.

Investigators ^ICMJE

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

Information Provided By

Park Nicollet Institute

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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