Type 2 DiabetesNCT00806520
Use of Continuous Glucose Monitoring Combined With Ambulatory Glucose Profiles to Characterize Glycemic Control
An observational study of Type 2 Diabetes, run by HealthPartners Institute at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 16 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2008to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants in the Amylin BCB106 Protocol Main Study
Who may be able to join
- 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
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- 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
Who cannot join
- liver disease
- renal disease
- cardiovascular disease
- gastroparesis
- cancer within 5 years of screening
- macular edema
Show all 18Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Joslin Diabetes Center
Boston, Massachusetts, 02215
University of North Carolina Diabetes Care Center
Durham, North Carolina, 27713
Palm Medical Group
Las Vegas, Nevada, 89148
International Diabetes Center
Minneapolis, Minnesota, 55416
Rockwood Clinic
Spokane, Washington, 99202
About this study
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)
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.
- Conditions
- Type 2 Diabetes
- Keywords
- Continuous Glucose Monitoring, Exenatide Once Weekly or, Januvia or, Actos
- Medical subject headings
- Diabetes Mellitus, Type 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study startApr 2008
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Amylin Pharmaceuticals, LLC.
- Responsible party
- Sponsor
- Investigators
- Richard M. Bergenstal, MD, Principal investigator, International Diabetes Center at Park NicolletRoger S. Mazze, PhD, Principal investigator, International Diabetes Center at Park NicolletRobert M. Cuddihy, MD, Principal investigator, International Diabetes Center at Park NicolletElinor (Ellie) S. Strock, APRN, BS,CDE, Principal investigator, International Diabetes Center at Park Nicollet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806520
- Sponsor's protocol ID
- 03671-08-C
- Status last verified
- Aug 2011
- First submitted
- 8 Dec 2008
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00806520
- Acronym / sponsor ID
- 03671-08-C
- Conditions
- Type 2 Diabetes
- Keywords
- Continuous Glucose Monitoring, Exenatide Once Weekly or, Januvia or, Actos
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- Amylin Pharmaceuticals, LLC.
- Study start
- Apr 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 10 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in the Amylin BCB106 Protocol Main Study
Key inclusion criteria (12 listed)
- 18 years or older
- type 2 diabetes
- A1c 7.1 - 11
- BMI 25 - 45
- stable weight for 3 months before screening
Key exclusion criteria (18 listed)
- liver disease
- renal disease
- cardiovascular disease
- gastroparesis
- cancer within 5 years of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard M. Bergenstal, MD principal investigator
International Diabetes Center at Park Nicollet
Roger S. Mazze, PhD principal investigator
International Diabetes Center at Park Nicollet
Robert M. Cuddihy, MD principal investigator
International Diabetes Center at Park Nicollet
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by HealthPartners Institute at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.