Type 2 DiabetesPhase 4MEXELINNCT00667732

How Glargine Insulin, Oral Diabetes Medications and Exenatide May Improve Blood Sugar Control and Weight Gain in Type 2 Diabetics

A Phase 4 study testing exenatide in people with Type 2 Diabetes, run by Oregon Health and Science University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study is designed to look at how using glargine insulin with oral diabetes medications and exenatide may improve control of blood sugar levels and weight gain in type 2 diabetics. The main study will last 32 weeks. Read more about this study

Who is it for?: Ages 30 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Type 2 Diabetes
What is being tested?: exenatide
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 41 participants
Where: 3 sitesUnited States
Study dates: Mar 2007to Apr 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 30 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or female patients with type 2 diabetes
Taking metformin at least 1000 mg daily plus a secretagogue, an alpha glucosidase inhibitor, a thiazolidinedione, or a single injection of any kind of insulin up to 0.4 units/kg daily for > 3 months
Age range 30 to 70 years
Body mass index 25-45 kg/m2
HbA1c 7.0 to 10.0% (or 7.0 to 8.5% if the second antihyperglycemic agent is insulin)
Less than 50% of randomized participants will have used insulin previously

Who cannot join

Use of more than two antihyperglycemic agents within the last 3 months
Use of more than one daily injection of any kind of insulin in the last 3 months
Positive anti-GAD antibody (test required in screening)
Fasting C-peptide <0.5 ng/mL (test required in screening)
Pregnancy (test required in screening if able to conceive) or lactation
Excessive use of alcohol or evidence of other form of drug dependency

Show all 17Show fewer

Unwillingness or inability to grant informed consent
Unwillingness or inability to perform self-monitoring of blood glucose
Unwillingness or inability to inject insulin and/or inject exenatide
Serum creatinine >1.3 mg/dL in women or 1.4 in men
Retinopathy which has required photocoagulation for treatment
Major active systemic illness (e.g. neoplastic disorder, symptomatic ischemic heart disease, congestive heart failure) that might interfere with performing the study protocol
Clinically significant gastrointestinal disorder including prior gastric or intestinal surgery for weight-control
Ongoing use of any drug (e.g. narcotic analgesic, tricyclic antidepressant) that might alter gastric emptying
Use prednisone or other systemic glucocorticoid drug in the last 3 months
Use of any drug for weight-control (e.g. sibutramine, phentermine, orlistat) in the last 3 months
Use of any unproven investigational drug within the last 3 months

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Oregon Health and Science University
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
Medstar Research Institute
Washington D.C., District of Columbia, 20003

Other trials in United States

About this study

Official title: Metformin, Exenatide, and Glargine Insulin in Combination for Treatment of Patients With Type 2 Diabetes

This study is designed to look at how using glargine insulin with oral diabetes medications and exenatide may improve control of blood sugar levels and weight gain in type 2 diabetics.

The main study will last 32 weeks. However, all participants completing 32 weeks will be invited to continue for another 24 weeks taking the insulin and oral medication and exenatide treatment. This extension comparing insulin and oral medication with insulin and oral medication and exenatide will look at the long term weight loss/gain and blood sugar level control effects of this new drug regimen.

There is also a sub-study in the Clinical Research Center (CRC), which requires two 38-hour inpatient stays during the main study. This study offers the opportunity to study 24-hour blood sugar and metabolic patterns quantitatively.

Conditions: Type 2 Diabetes
Being tested: exenatide, placebo
Keywords: diabetes, insulin, byetta, glucose, blood sugar, metformin, A1c
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

exenatideDrug
Also called Byetta
5mcg twice a day, increasing to 10mcg twice a day for 24 weeks
placeboDrug
5mcg twice a day, increased to 10mcg twice a day for 24 weeks

Study groups in NCT00667732
Study group	Role	What they receive
1	Active comparator	Participants will receive exenatide as part of their diabetes treatment Receives: Drug: exenatide
2	Placebo comparator	Participants will receive placebo rather than exenatide as part of their diabetes treatment Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

The Percentage of Intent to Treat Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment
Measured: After 24 weeks of randomized treatment

Secondary outcomes (1)

The Percentage of Per Protocol Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment
efficacy criteria, 50% of per protocol participants reached A1c target of <6.5%
Measured: After 24 weeks of randomized treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2007Apr 2010

First posted28 Apr 2008 (estimated)
Study startMar 2007
Primary completionOct 2009
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by Oregon Health and Science UniversityThe 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00667732
Sponsor's protocol ID: IND 75,235
Acronym: MEXELIN
Status last verified: Feb 2013
First submitted: 24 Apr 2008
Last updated: 6 Feb 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Metformin, Exenatide, and Glargine Insulin in Combination for Treatment of Patients With Type 2 Diabetes
ClinicalTrials.gov ID: NCT00667732
Acronym / sponsor ID: MEXELIN / IND 75,235
Conditions: Type 2 Diabetes
Keywords: diabetes, insulin, byetta, glucose, blood sugar, metformin, A1c
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Oregon Health and Science UniversityUniversity, hospital or other
Collaborators: Amylin Pharmaceuticals, LLC., Eli Lilly and Company
Study start: Mar 2007
Primary completion: Oct 2009 (actual)
Study completion: Apr 2010 (actual)
First posted: 28 Apr 2008 (estimated)
Results: Posted 6 Feb 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is designed to look at how using glargine insulin with oral diabetes medications and exenatide may improve control of blood sugar levels and weight gain in type 2 diabetics.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Drug: exenatideParticipants will receive exenatide as part of their diabetes treatment
2	Placebo comparator	Drug: placeboParticipants will receive placebo rather than exenatide as part of their diabetes treatment

Who may qualify

Ages: 30 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Male or female patients with type 2 diabetes
Taking metformin at least 1000 mg daily plus a secretagogue, an alpha glucosidase inhibitor, a thiazolidinedione, or a single injection of any kind of insulin up to 0.4 units/kg daily for > 3 months
Age range 30 to 70 years
Body mass index 25-45 kg/m2
HbA1c 7.0 to 10.0% (or 7.0 to 8.5% if the second antihyperglycemic agent is insulin)

Key exclusion criteria (17 listed)

Use of more than two antihyperglycemic agents within the last 3 months
Use of more than one daily injection of any kind of insulin in the last 3 months
Positive anti-GAD antibody (test required in screening)
Fasting C-peptide <0.5 ng/mL (test required in screening)
Pregnancy (test required in screening if able to conceive) or lactation

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: Byetta5mcg twice a day, increasing to 10mcg twice a day for 24 weeks	Drug	1
placebo5mcg twice a day, increased to 10mcg twice a day for 24 weeks	Drug	2

Primary outcome

The Percentage of Intent to Treat Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment
Time frame: After 24 weeks of randomized treatment

1 secondary outcome

The Percentage of Per Protocol Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment
Time frame: After 24 weeks of randomized treatment

Results and safety

Results posted to the registry on 6 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Run-In Group	41	34
Exenatide Group	0	0
Placebo Group	0	0

Primary outcome: The Percentage of Intent to Treat Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment

Time frame: After 24 weeks of randomized treatment. Number. Unit: percentage of participants

Measure	Exenatide Group n = 17	Placebo Group n = 17
Value	47 (5.7 to 9.3)	12 (5.7 to 9.8)

Population analysed: Intent to treat. All participants randomized to treatment.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were reported from the screening visit to final clinic visit totaling 59 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Run-In Group	0 of 38 (0%)	21 of 38 (55.3%)	Not reported
Exenatide Randomization Group	0 of 17 (0%)	15 of 17 (88.2%)	Not reported
Placebo Randomization Period	0 of 17 (0%)	10 of 17 (58.8%)	Not reported
Exenatide Open-Label (Previous Exenatide)	0 of 14 (0%)	11 of 14 (78.6%)	Not reported
Exenatide Open-Label (Previous Placebo)	0 of 17 (0%)	12 of 17 (70.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Type 2 Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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.

Matthew Riddle, MD principal investigator

Oregon Health and Science University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing exenatide in people with Type 2 Diabetes, run by Oregon Health and Science University at 3 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 6 inclusion and 17 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 6 Feb 2013. 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 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. 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Percentage of Intent to Treat Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment (time frame: After 24 weeks of randomized treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00667732.

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 6 Feb 2013.