Type 2 DiabetesPhase 2/3EXEPUMPNCT01140893
Effects of Exenatide on Glycemic Control and Weight in Continuous Subcutaneous Insulin Infusion (CSII) Type 2 Treated Patients With Type 2 Diabetes
A Phase 2/3 study testing Exenatide in people with Type 2 Diabetes, run by University Hospital, Caen at 3 sites in France.
Trial summary
The purpose of this study is to determine whether exenatide is effective to improve glycemic control among type 2 diabetic patients treated by insulin pump therapy. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Exenatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 3 sitesFrance
- Study dates
- Nov 2010to May 2017
- Phase
- Phase 2/3
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged 35 to 70
- Type 2 diabetes diagnosed for at least 12 months, according the criteria of the American Diabetes Association :
- presence of classic symptoms of diabetes mellitus with unequivocal elevation of plasma glucose (2-hour post-prandial or random glucose >200 mg/dL) or
- fasting plasma glucose elevation on more than 1 occasion > 125 mg/dL or
- patient currently undergoing pharmacological and/or non-pharmacological treatment for diabetes mellitus
- CSII treatment using a rapid analog for at least 6 month (CSII being initiated in patients with HbA1c > 8 % despite a well-conducted MDI trial using a 2 to 5 daily injection regimen)
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- HbA1c ≥ 7,5% and ≤ 10 %
- BMI ≥ 25 and ≤ 45
- Stable body weight (≤10% variation) during the 3 last months
Who cannot join
- Type 1 diabetes assessed by positive anti-GAD65 or anti-insulin or anti-IA2 antibodies
- Monogenic diabetes (MODY, mitochondrial diabetes…)
- Current treatment with OHA (OHA ought to be interrupted at least two months prior to inclusion in the study)
- Current treatment specifically addressed for weight lost (orlistat, sibutramine, rimonabant may be interrupted at least 3 months prior to inclusion in the study)
- Use of corticosteroid therapy for more than 10 days within the 3-past months, or patient who ought to be treated by corticosteroid during the study period
- Clinically significant hepatic disease
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- Documented gastroparesis, or current use of drugs that directly affect gastrointestinal motility, or any significant abdominal disease that may increase the risk of adverse gastrointestinal effects induced by exenatide
- Kidney failure (MDRD less than 50 ml/min)
- Pregnancy/breastfeeding
- Any social and/or mental condition rendering the subject unable to understand the scope and possible consequences of the study
- Concurrent enrolment in another clinical trial
- Geographically inaccessible for follow-up visits required by protocol
Trial locations and contacts
3 sites in 1 country.
Michael Joubert, MD contact
Yves Reznik, MD contact
France3 sites, 3 recruiting
- Recruiting
Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen
Caen, 14000
+33 2 31 06 45 75
Michael JOUBERT, MD
- Recruiting
CERIDT
Corbeil-Essonne
Guillaume Charpentier, MD
- Not yet recruiting
Endocrinology Unit
Strasbourg
Nathalie Jeandidier, MD, PhD
About this study
Official title: Effects of EXEnatide on Glycemic Control and Weight Over 26 Weeks in Continuous Subcutaneous Insulin Infusion (CSII) Treated Patients With Type 2 Diabetes : a Phase 2/3 Double Blind randoMized Placebo-controlled Trial.
The purpose of this study is to determine whether exenatide is effective to improve glycemic control among type 2 diabetic patients treated by insulin pump therapy.
- Conditions
- Type 2 Diabetes
- Being tested
- Exenatide, Placebo
- Keywords
- Type 2 diabetes, CSII, Exenatide, Double Blind Placebo Controlled Study
- 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.
ExenatideDrug
Also called Exenatide = BYETTA (R)
Research drug (exenatide or placebo), will begin at V0, after randomization. The initial dosage for the first month will be 5 µg SC BID. Injections can be administered at any time within the 60 minute period before the morning and evening meal.
From V1, research drug will be titrated from 5 to 10 µg SC BID. If gastro-intestinal adverse effects occur with 10 µg SC BID, the dosage will be back-titrated to 5 µg SC BID. Thus, the higher research drug dosage tolerated will be used during the study time.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| exenatide | Experimental | 55 subjects Receives: Drug: Exenatide |
| Placebo | Placebo comparator | 55 subjects Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to 6 months of centrally measured HbA1c
Measured: baseline to 6 months
Secondary outcomes (2)
Change from baseline in weight, BMI, waist circumference, 6 points glucose profile, insulin doses, % of daily use of insulin as basal rate, % of daily use of insulin as bolus, quality of life questionnaire
Measured: baseline to 6 months
Change from baseline in mean blood glucose value
occurrence of hyperglycemia above 190 mg/dl expressed as Area under the Curve (high) above 190 mg/dl (10.5 mmol/l), occurrence of hypoglycemia below 70 mg/dl (3.9 mmol/l) expressed as Area Under the Curve (low) below 70 mg/dl, glycemic variability (MAGE index).
Measured: baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startNov 2010
- Primary completionMay 2017 (estimated)
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.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Michael JOUBERT, MD, Principal investigator, Endocrinology Unit, University Hospital of Caen, FRANCEYves REZNIK, MD, Principal investigator, Endocrinology Unit, University Hospital of Caen, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140893
- Sponsor's protocol ID
- EudraCT N° 2009-016384-11
- Acronym
- EXEPUMP
- Status last verified
- Jul 2016
- First submitted
- 3 May 2010
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of EXEnatide on Glycemic Control and Weight Over 26 Weeks in Continuous Subcutaneous Insulin Infusion (CSII) Treated Patients With Type 2 Diabetes : a Phase 2/3 Double Blind randoMized Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT01140893
- Acronym / sponsor ID
- EXEPUMP / EudraCT N° 2009-016384-11
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, CSII, Exenatide, Double Blind Placebo Controlled Study
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Nov 2010
- Primary completion
- May 2017 (estimated)
- First posted
- 10 Jun 2010 (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 study is to determine whether exenatide is effective to improve glycemic control among type 2 diabetic patients treated by insulin pump therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exenatide | Experimental | Drug: Exenatide55 subjects |
| Placebo | Placebo comparator | Drug: Placebo55 subjects |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men or women aged 35 to 70
- Type 2 diabetes diagnosed for at least 12 months, according the criteria of the American Diabetes Association :
- CSII treatment using a rapid analog for at least 6 month (CSII being initiated in patients with HbA1c > 8 % despite a well-conducted MDI trial using a 2 to 5 daily injection regimen)
- HbA1c ≥ 7,5% and ≤ 10 %
- BMI ≥ 25 and ≤ 45
Key exclusion criteria (12 listed)
- Type 1 diabetes assessed by positive anti-GAD65 or anti-insulin or anti-IA2 antibodies
- Monogenic diabetes (MODY, mitochondrial diabetes…)
- Current treatment with OHA (OHA ought to be interrupted at least two months prior to inclusion in the study)
- Current treatment specifically addressed for weight lost (orlistat, sibutramine, rimonabant may be interrupted at least 3 months prior to inclusion in the study)
- Use of corticosteroid therapy for more than 10 days within the 3-past months, or patient who ought to be treated by corticosteroid during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExenatideAlso: Exenatide = BYETTA (R)Research drug (exenatide or placebo), will begin at V0, after randomization. The initial dosage for the first month will be 5 µg SC BID. Injections can be administered at any time within the 60 minute period before the morning and evening meal. From V1, research drug will be titrated from 5 to 10 µg SC BID. If gastro-intestinal adverse effects occur with 10 µg SC BID, the dosage will be back-titrated to 5 µg SC BID. Thus, the higher research drug dosage tolerated will be used during the study time. | Drug | exenatide |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change from baseline to 6 months of centrally measured HbA1c
Time frame: baseline to 6 months
2 secondary outcomes
Change from baseline in weight, BMI, waist circumference, 6 points glucose profile, insulin doses, % of daily use of insulin as basal rate, % of daily use of insulin as bolus, quality of life questionnaire
Time frame: baseline to 6 months
Change from baseline in mean blood glucose value
Time frame: baseline to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2016.
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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.
Michael Joubert, MD contact
Yves Reznik, MD contact
Michael JOUBERT, MD principal investigator
Endocrinology Unit, University Hospital of Caen, FRANCE
Yves REZNIK, MD principal investigator
Endocrinology Unit, University Hospital of Caen, FRANCE
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Exenatide in people with Type 2 Diabetes, run by University Hospital, Caen at 3 sites in France.
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 9 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 23 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Joubert, MD (joubert-m@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to 6 months of centrally measured HbA1c (time frame: baseline to 6 months). 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 23 Aug 2016.