Type 2 Diabetes MellitusNCT00803920
Continuous Glucose Monitoring (CGM) in Subjects With Type 2 Diabetes Taking Twice-Daily Exenatide or Once-Weekly Exenatide
An observational study of Type 2 Diabetes Mellitus, run by HealthPartners Institute at 1 site in United States.
Trial summary
The purpose of this substudy is to obtain CGM data from individuals taking exenatide. The CGM measurements gathered before starting and during treatment with exenatide IR and/or exenatide LAR will help determine the characteristics of glucose control during treatment. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Feb 2008
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Up to eighteen subjects at the International Diabetes Center study site will be selected for this substudy in accordance with protocol 2993LAR-105
Who may be able to join
- participant in Amylin Protocol 2993LAR-105
- at least 16 years of age
- type 2 diabetes being treated with stable regiment of metformin, SU, TZD, combination of metformin/SU, combination metformin/TZD, combination SU/TZD
- A1c 7.1 - 11
- fasting glucose less than 280 at screening
- BMI 25 - 45
Show all 11Show fewer
- stable body weight 6 months prior to screening
- not pregnant and willing to practice birth control
- physical exam \& ECG not clinically significant
- lab values judged not to be clinically significant
- able to understand \& sign consent form
Who cannot join
- clinically significant medical condition as judged by investigator
- drug or alcohol abuse
- previous use of exenatide or any GLP-1 analog
- has used any investigational drug in the past 30 days prior to screening
- is currently using: alpha-glucosidase inhibitor, insulin, drugs that affect GI motility, use of systemic corticosteroids, use of medications with addictive potential, prescription or OTC weight-loss medications
- has donated blood within 60 days of screening, or is planning to donate during the study
Show all 11Show fewer
- has had major surgery or blood transfusion within 2 months of screening
- has had a surgical procedure that may impact gastric emptying
- has any allergies or hypersensitivity to any component of study treatment
- is an immediate family member of personnel affiliated with the study at the investigative site
- is employed by Amylin, Lilly or Alkermes
Trial locations and contacts
1 site in 1 country.
United States1 site
International Diabetes Center
Minneapolis, Minnesota, 55416
About this study
Official title: CGM Substudy, Addendum 2, of the Following Exenatide LAR Protocol 2993LAR-105: A Randomized, Open-Label, Multicenter, Comparator Controlled Study to Examine the Effects of Exenatide Long-Acting Release on Glucose Control (HbA1c) and Safety in Subjects With Type 2 Diabetes Mellitus Managed With Diet Modification and Exercise and/or Oral Antidiabetic Medications)
The purpose of this substudy is to obtain CGM data from individuals taking exenatide. The CGM measurements gathered before starting and during treatment with exenatide IR and/or exenatide LAR will help determine the characteristics of glucose control during treatment.
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- exenatide twice daily or once weekly, continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exenatide | Not described | |
| Exenatide LAR | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize glucose control using periodic CGM in subjects participating in protocol 2993LAR-105 at the International Diabetes Center study site.
Baseline CGM will be performed from Visit 2 to Visit 3 for approximately 14 days followed by a second CGM period from Visit 3 to Visit 6 for approximately 17 days. At Week 28, two weeks after Visit 14 (Week 26), subjects will be instructed to begin CGM and to continue through Visit 20 (Week 30) for Group A subjects or Visit 22 (Week 32) for Group B subjects. At Week 50, two weeks after Visit 28 (Week 48), subjects will be instructed to begin the final CGM period and to continue monitoring until the next study visit at Visit 29 (Week 52)
Measured: 2 week periods of time - 3 times during study:
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startDec 2006
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- 8 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, Park Nicollet Institute dba International Diabetes CenterElinor S Strock, APRN, BC, Principal investigator, Park Nicollet Institute dba International Diabetes CenterRoger S Mazze, PhD, Principal investigator, Park Nicollet Institute dba International Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803920
- Sponsor's protocol ID
- 03404-06-C
- Status last verified
- Aug 2013
- First submitted
- 4 Dec 2008
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CGM Substudy, Addendum 2, of the Following Exenatide LAR Protocol 2993LAR-105: A Randomized, Open-Label, Multicenter, Comparator Controlled Study to Examine the Effects of Exenatide Long-Acting Release on Glucose Control (HbA1c) and Safety in Subjects With Type 2 Diabetes Mellitus Managed With Diet Modification and Exercise and/or Oral Antidiabetic Medications)
- ClinicalTrials.gov ID
- NCT00803920
- Acronym / sponsor ID
- 03404-06-C
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- exenatide twice daily or once weekly, continuous glucose monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- Amylin Pharmaceuticals, LLC.
- Study start
- Dec 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 8 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.
The purpose of this substudy is to obtain CGM data from individuals taking exenatide. The CGM measurements gathered before starting and during treatment with exenatide IR and/or exenatide LAR will help determine the characteristics of glucose control during treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exenatide | – | – |
| Exenatide LAR | – | – |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Up to eighteen subjects at the International Diabetes Center study site will be selected for this substudy in accordance with protocol 2993LAR-105
Key inclusion criteria (11 listed)
- participant in Amylin Protocol 2993LAR-105
- at least 16 years of age
- type 2 diabetes being treated with stable regiment of metformin, SU, TZD, combination of metformin/SU, combination metformin/TZD, combination SU/TZD
- A1c 7.1 - 11
- fasting glucose less than 280 at screening
Key exclusion criteria (11 listed)
- clinically significant medical condition as judged by investigator
- drug or alcohol abuse
- previous use of exenatide or any GLP-1 analog
- has used any investigational drug in the past 30 days prior to screening
- is currently using: alpha-glucosidase inhibitor, insulin, drugs that affect GI motility, use of systemic corticosteroids, use of medications with addictive potential, prescription or OTC weight-loss medications
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
Characterize glucose control using periodic CGM in subjects participating in protocol 2993LAR-105 at the International Diabetes Center study site.
Time frame: 2 week periods of time - 3 times during study:
Baseline CGM will be performed from Visit 2 to Visit 3 for approximately 14 days followed by a second CGM period from Visit 3 to Visit 6 for approximately 17 days. At Week 28, two weeks after Visit 14 (Week 26), subjects will be instructed to begin CGM and to continue through Visit 20 (Week 30) for Group A subjects or Visit 22 (Week 32) for Group B subjects. At Week 50, two weeks after Visit 28 (Week 48), subjects will be instructed to begin the final CGM period and to continue monitoring until the next study visit at Visit 29 (Week 52)
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 3 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
Park Nicollet Institute dba International Diabetes Center
Elinor S Strock, APRN, BC principal investigator
Park Nicollet Institute dba International Diabetes Center
Roger S Mazze, PhD principal investigator
Park Nicollet Institute dba International Diabetes Center
1 site 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 Mellitus, run by HealthPartners Institute at 1 site 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 11 inclusion and 11 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 3 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 1 site 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.
What does the primary outcome measure?
Characterize glucose control using periodic CGM in subjects participating in protocol 2993LAR-105 at the International Diabetes Center study site. (time frame: 2 week periods of time - 3 times during study:). It is what the study was designed to measure, not a finding.
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 3 Dec 2015.