Type 2 Diabetes MellitusPhase 4NCT00729326
Comparison of the Effect of Exenatide Versus Sitagliptin on 24-hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione
A Phase 4 study testing exenatide and sitagliptin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 1 site in United States.
Trial summary
This study is designed to compare the short-term effects and mechanisms of action of exenatide with those of sitagliptin when either is added to an oral agent(metformin or a thiazolidinedione [TZD]) in adult patients with type 2 diabetes mellitus(T2DM) with inadequate glycemic control. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- exenatide and sitagliptin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Oct 2009
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have type 2 diabetes
- Has HbA1c 7.0% to 11.0%, at or within 4 weeks prior to Visit 1.
- Have a fasting glucose concentration <280 mg/dL at Visit 1
- Have been treated with a stable dose of immediate or extended release metformin for at least 60 days prior to screening OR TZD (rosiglitazone or pioglitazone) for at least 120 days prior to screening.
- Are between 18 and 70 years of age, inclusive.
- Have body mass index ≥25 kg/m2 and ≤45 kg/m2.
- Have a history of stable body weight (not varying by >10% for at least 3 months prior to screening).
- Can swallow oral study drug capsule, without splitting or crushing.
Who cannot join
- Female patients of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause) who meet any of the following criteria:
- Are breastfeeding.
- Test positive for pregnancy at the time of screening.
- Intend to become pregnant during the study.
- Have not practiced a reliable method of birth control (for example, use of oral contraceptives or Norplant®; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) for 3 months prior to screening.
- Treated with any of the following medications:
Show all 18Show fewer
- Insulin, exenatide, pramlintide, sulfonylureas or meglitinides within 3 months of screening
- Alpha-glucosidase inhibitor within 2 months of screening.
- Drugs that directly affect gastrointestinal motility, including, but not limited to metoclopramide, cisapride, and chronic macrolide antibiotics.
- Use of a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phentermine, or similar over-the-counter medications) within 3 months prior to Visit 1.
- Systemic corticosteroids by oral, intravenous, or intramuscular route within 2 months of screening.
- Have a history of renal transplantation or are currently receiving renal dialysis.
- Have obvious clinical signs or symptoms of liver disease or acute or chronic hepatitis.
- Have known active proliferative retinopathy or macular edema expected to need treatment with focal photocoagulation within 3 months.
- Have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
- Have had organ transplantation.
- Have received GLP-1 analogs other than exenatide or DPP-4 inhibitors within the previous 3 months.
- Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Exenatide vs. Sitagliptin on 24-hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione
This study is designed to compare the short-term effects and mechanisms of action of exenatide with those of sitagliptin when either is added to an oral agent(metformin or a thiazolidinedione [TZD]) in adult patients with type 2 diabetes mellitus(T2DM) with inadequate glycemic control.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- exenatide, sitagliptin, placebo
- Keywords
- diabetes, exenatide, sitagliptin, Amylin, Lilly, metformin, thiazolidinedione
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exenatideDrug
Also called Byetta
subcutaneous injection (5mcg or 10mcg), twice a day
sitagliptinDrug
Also called Januvia
oral administration (100mg), once a day in the morning
placeboDrug
subcutaneous injection (5mcg or 10mcg), twice a day
placeboDrug
oral administration (100mg), once a day in the morning
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Not described Receives: Drug: exenatide; Drug: sitagliptin; Drug: placebo |
| Sequence B | Experimental | Not described Receives: Drug: exenatide; Drug: sitagliptin; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Time-averaged Glucose During a 24 Hour Period
Change in time-averaged glucose during a 24-hour period from baseline to endpoint (i.e., time-averaged glucose over 24 hours at endpoint minus time-averaged glucose over 24 hours at baseline).
Measured: baseline and 8 Weeks
Secondary outcomes (18)
Change in Two-hour Postprandial Glucose After the Morning Meal
Change in 2 hour post-prandial glucose after the morning meal from baseline to endpoint (i.e., glucose level 2 hours after the morning meal at baseline minus glucose level 2 hours after the morning meal at endpoint)
Measured: baseline and 8 Weeks
Change in Fasting Blood Glucose After the Morning Meal
Change in fasting blood glucose after the morning meal from baseline to endpoint (i.e., fasting blood glucose after the morning meal at baseline minus fasting blood glucose after the morning meal at endpoint)
Measured: baseline and 8 Weeks
Change in Postprandial Glucagon Area Under the Concentration-time Curve (AUC) After the Morning Meal
Change in Postprandial Glucagon AUC after the morning meal (t=0 to 4 hours) (i.e., Glucagon AUC over the first 4 hours following the morning meal at baseline minus glucagon AUC over the first 4 hours following the morning meal at endpoint)
Measured: baseline and 8 Weeks
Change in Postprandial Glucagon AUC Excursion After the Morning Meal
Change in postprandial glucagon AUC excursion after the morning meal (t=0 to 4 hours) (i.e., glucagon AUC excursion for 4 hours following the morning meal at baseline minus glucagon AUC excursion for 4 hours following the morning meal at endpoint)
Measured: baseline and 8 Weeks
Change in Postprandial Triglyceride AUC After the Morning Meal
Change in postprandial triglyceride AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC after the morning meal at baseline minus postprandial triglyceride AUC after the morning meal at endpoint)
Measured: baseline and 8 Weeks
Change in Postprandial Triglyceride AUC Excursion After the Morning Meal
Change in postprandial triglyceride AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC excursion after the morning meal at baseline minus postprandial triglyceride AUC excursion after the morning meal at endpoint)
Measured: baseline and 8 Weeks
Change in Postprandial C-peptide AUC After the Morning Meal
Change in postprandial C-peptide AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC after the morning meal at baseline minus postprandial C-peptide AUC after the morning meal at endpoint)
Measured: baseline and 8 Weeks
Change in Postprandial C-peptide AUC Excursion After the Morning Meal
Change in Postprandial C-peptide AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC excursion after the morning meal at baseline minus postprandial C-peptide AUC excursion after the morning meal at endpoint)
Measured: baseline and 8 Weeks
Change in Postprandial Insulin AUC After the Morning Meal
Change in postprandial insulin AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC after the morning meal at baseline minus postprandial insulin AUC after the morning meal at endpoint)
Measured: baseline and 8 Weeks
Change in Postprandial Insulin AUC Excursion After the Morning Meal
Change in Postprandial insulin AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC excursion after the morning meal at baseline minus postprandial insulin AUC excursion after the morning meal at endpoint)
Measured: baseline and 8 Weeks
Change in Postprandial Active GLP-1 AUC After the Morning Meal
Change in Postprandial active GLP-1 AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC after the morning meal at baseline minus postprandial active GLP-1 AUC after the morning meal at endpoint)
Measured: baseline and 8 Weeks
Change in Postprandial Active GLP-1 AUC Excursion After the Monrning Meal
Change in Postprandial active GLP-1 AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC excursion after the morning meal at baseline minus postprandial active GLP-1 AUC excursion after the morning meals at endpoint)
Measured: baseline and 8 Weeks
Percentage of Patients Experiencing Hypoglycemia (Baseline to Week 4)
Percentage of patients experiencing minor hypoglycemia with a confirmed glucose <54mg/dL
Measured: 4 Weeks
Episodes of Hypoglycemia (Baseline to Week 4)
Number of episodes of hypoglycemia experienced during the first 4 weeks of the study
Measured: 4 weeks
Percentage of Patients Experiencing Hypoglycemia (Week 4 to Week 8)
Percentage of patients experiencing minor hypoglycemia with a confirmed glucose <54mg/dL
Measured: 8 weeks
Episodes of Hypoglycemia (Week 4 to Week 8)
Number of episodes of hypoglycemia experienced between week 4 and week 8 of the study
Measured: 8 weeks
Percentage of Patients Experiencing Hypoglycemia (Overall)
Percentage of patients experiencing minor hypoglycemia with a confirmed glucose <54mg/dL
Measured: 4 weeks and 8 weeks
Episodes of Hypoglycemia (Overall)
Number of episodes of hypoglycemia experienced overall during the study
Measured: 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionOct 2009
- Study completionOct 2009
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 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, MD, Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729326
- Sponsor's protocol ID
- H8O-US-GWCV
- Status last verified
- Mar 2015
- First submitted
- 4 Aug 2008
- Last updated
- 9 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Exenatide vs. Sitagliptin on 24-hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione
- ClinicalTrials.gov ID
- NCT00729326
- Acronym / sponsor ID
- H8O-US-GWCV
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes, exenatide, sitagliptin, Amylin, Lilly, metformin, thiazolidinedione
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- Aug 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 7 Aug 2008 (estimated)
- Results
- Posted 20 Jan 2011
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 compare the short-term effects and mechanisms of action of exenatide with those of sitagliptin when either is added to an oral agent(metformin or a thiazolidinedione [TZD]) in adult patients with type 2 diabetes mellitus(T2DM) with inadequate glycemic control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: exenatide, Drug: sitagliptin, Drug: placebo |
| Sequence B | Experimental | Drug: exenatide, Drug: sitagliptin, Drug: placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have type 2 diabetes
- Has HbA1c 7.0% to 11.0%, at or within 4 weeks prior to Visit 1.
- Have a fasting glucose concentration <280 mg/dL at Visit 1
- Have been treated with a stable dose of immediate or extended release metformin for at least 60 days prior to screening OR TZD (rosiglitazone or pioglitazone) for at least 120 days prior to screening.
- Are between 18 and 70 years of age, inclusive.
Key exclusion criteria (18 listed)
- Female patients of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause) who meet any of the following criteria:
- Treated with any of the following medications:
- Have a history of renal transplantation or are currently receiving renal dialysis.
- Have obvious clinical signs or symptoms of liver disease or acute or chronic hepatitis.
- Have known active proliferative retinopathy or macular edema expected to need treatment with focal photocoagulation within 3 months.
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: Byettasubcutaneous injection (5mcg or 10mcg), twice a day | Drug | Sequence A, Sequence B |
| sitagliptinAlso: Januviaoral administration (100mg), once a day in the morning | Drug | Sequence A, Sequence B |
| placebosubcutaneous injection (5mcg or 10mcg), twice a day | Drug | Sequence A, Sequence B |
| placebooral administration (100mg), once a day in the morning | Drug | Sequence A, Sequence B |
Primary outcome
Change in Time-averaged Glucose During a 24 Hour Period
Time frame: baseline and 8 Weeks
Change in time-averaged glucose during a 24-hour period from baseline to endpoint (i.e., time-averaged glucose over 24 hours at endpoint minus time-averaged glucose over 24 hours at baseline).
18 secondary outcomes
Change in Two-hour Postprandial Glucose After the Morning Meal
Time frame: baseline and 8 Weeks
Change in Fasting Blood Glucose After the Morning Meal
Time frame: baseline and 8 Weeks
Change in Postprandial Glucagon Area Under the Concentration-time Curve (AUC) After the Morning Meal
Time frame: baseline and 8 Weeks
Change in Postprandial Glucagon AUC Excursion After the Morning Meal
Time frame: baseline and 8 Weeks
Change in Postprandial Triglyceride AUC After the Morning Meal
Time frame: baseline and 8 Weeks
Change in Postprandial Triglyceride AUC Excursion After the Morning Meal
Time frame: baseline and 8 Weeks
Change in Postprandial C-peptide AUC After the Morning Meal
Time frame: baseline and 8 Weeks
Change in Postprandial C-peptide AUC Excursion After the Morning Meal
Time frame: baseline and 8 Weeks
Change in Postprandial Insulin AUC After the Morning Meal
Time frame: baseline and 8 Weeks
Change in Postprandial Insulin AUC Excursion After the Morning Meal
Time frame: baseline and 8 Weeks
Change in Postprandial Active GLP-1 AUC After the Morning Meal
Time frame: baseline and 8 Weeks
Change in Postprandial Active GLP-1 AUC Excursion After the Monrning Meal
Time frame: baseline and 8 Weeks
Percentage of Patients Experiencing Hypoglycemia (Baseline to Week 4)
Time frame: 4 Weeks
Episodes of Hypoglycemia (Baseline to Week 4)
Time frame: 4 weeks
Percentage of Patients Experiencing Hypoglycemia (Week 4 to Week 8)
Time frame: 8 weeks
Episodes of Hypoglycemia (Week 4 to Week 8)
Time frame: 8 weeks
Percentage of Patients Experiencing Hypoglycemia (Overall)
Time frame: 4 weeks and 8 weeks
Episodes of Hypoglycemia (Overall)
Time frame: 4 weeks and 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Chief Medical Officer, MD study director
Eli Lilly and Company
1 site 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 and sitagliptin in people with Type 2 Diabetes Mellitus, run by AstraZeneca 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 8 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 9 Apr 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.
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 20 Jan 2011). 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?
Change in Time-averaged Glucose During a 24 Hour Period (time frame: baseline and 8 Weeks). 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 9 Apr 2015.