Type 1 DiabetesPhase 4NCT01718093
A Pilot Study to Assess the Glucose Lowering Effect of Metformin and Sitagliptin in Adolescents With Type 1 Diabetes
A Phase 4 study testing Sitagliptin, Metformin and Sitagliptin + Metformin in people with Type 1 Diabetes, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to see if the use of metformin and sitagliptin used in conjunction with insulin can improve the blood sugars of teenagers with Type 1 diabetes. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Sitagliptin, Metformin and Sitagliptin + Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Dec 2015
- Phase
- Phase 4
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age of 13 to 18 years
- HbA1c >7.5% but <10%
- Subjects must be on intensive insulin management
- Tanner stage greater than or equal to 4
- Must have T1DM for at least one year , T1DM defined by ADA criteria and having at least one of the following antibodies: Anti-GAD, Anti-islet, Anti-insulin
- C-peptide > 0.6 ng/ml
Who cannot join
- Type 2 diabetes
- History of any other chronic condition (except hypothyroidism stable on medications)
- Actively taking medications that may affect glucose excursions (steroids or oral contraceptives)
- Evidence of anemia, clinically significant elevation of the liver enzymes (3 X normal), amylase or lipase (2 X normal), abnormal triclycerides (3 X normal), abnormal renal function test
- An unsupportive family environment and pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Assess the Glucose Lowering Effect of Metformin and Sitagliptin in Adolescents With Type 1 Diabetes Mellitus
The purpose of this study is to see if the use of metformin and sitagliptin used in conjunction with insulin can improve the blood sugars of teenagers with Type 1 diabetes.
Read the detailed description
- The study will include a total of 4 visits. The time period between the very first visit and the very last visit will be between 10 and 15 weeks. Each participant will be randomized to one of the 3 groups in the study. The groups are as follows:
- Group 1: Insulin and sitagliptin
- Group 2: Insulin and metformin
- Group 3: Insulin and combination of sitagliptin and metformin
- The study is a randomized open label design. All subjects will undergo a screening visit; if inclusion and exclusion criteria are fulfilled they will be enrolled in the study. At the time of enrollment the subject will continue their home insulin regimen and will be randomized to an add an oral hypoglycemic agent(s) : metformin, sitagliptin or combination therapy (metformin and sitagliptin). The total duration on study medication will be 6 weeks. All subjects will undergo a baseline mixed meal tolerance test (MMTT) in their standard or usual insulin Each subject will undergo a total of two studies. Blood draws will be necessary.
- Conditions
- Type 1 Diabetes
- Being tested
- Sitagliptin, Metformin, Sitagliptin + Metformin
- Keywords
- Adolescents
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
Also called Januvia
up to 50 mg twice a day
MetforminDrug
Also called Glucophage
up to 1000 mg twice a day
Sitagliptin + MetforminDrug
Also called Sitagliptin + Metformin = Janumet
up to 50/1000 mg twice a day
| Study group | Role | What they receive |
|---|---|---|
| Insulin plus sitagliptin | Active comparator | The subjects continued their usual insulin regimen throughout the study. Sitagliptin was started and continued at 50 mg orally twice daily Receives: Drug: Sitagliptin |
| Insulin plus metformin | Active comparator | The subjects continued their usual insulin regimen throughout the study. Metformin was started at 500 mg orally daily. The dose was increased over a 2 week period up to 2,000 mg per day as tolerated. Receives: Drug: Metformin |
| Insulin plus sitagliptin and metformin | Active comparator | The subjects continued their usual insulin regimen throughout the study. Sitagliptin was started and continued at 50 mg orally twice daily. Metformin was started at 500 mg orally daily. The dose was increased over a 2 week period up to 2,000 mg per day as tolerated. Receives: Drug: Sitagliptin + Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the glucose lowering effect of metformin and sitagliptin alone and as combination therapy when used as adjuncts to insulin in adolescents with T1DM.
Glucose concentrations and AUC glucose calculation
Measured: 10 - 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luisa M. Rodriguez, Baylor College of Medicine
- Investigators
- Luisa M. Rodriguez, MD, MS, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718093
- Sponsor's protocol ID
- H-29924
- Other IDs
- DK096067
- Status last verified
- Apr 2017
- First submitted
- 29 Oct 2012
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Glucose Lowering Effect of Metformin and Sitagliptin in Adolescents With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01718093
- Acronym / sponsor ID
- H-29924
- Conditions
- Type 1 Diabetes
- Keywords
- Adolescents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2012 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 31 Oct 2012 (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 see if the use of metformin and sitagliptin used in conjunction with insulin can improve the blood sugars of teenagers with Type 1 diabetes.
Detailed description
- The study will include a total of 4 visits. The time period between the very first visit and the very last visit will be between 10 and 15 weeks. Each participant will be randomized to one of the 3 groups in the study. The groups are as follows:
- Group 1: Insulin and sitagliptin
- Group 2: Insulin and metformin
- Group 3: Insulin and combination of sitagliptin and metformin
- The study is a randomized open label design. All subjects will undergo a screening visit; if inclusion and exclusion criteria are fulfilled they will be enrolled in the study. At the time of enrollment the subject will continue their home insulin regimen and will be randomized to an add an oral hypoglycemic agent(s) : metformin, sitagliptin or combination therapy (metformin and sitagliptin). The total duration on study medication will be 6 weeks. All subjects will undergo a baseline mixed meal tolerance test (MMTT) in their standard or usual insulin Each subject will undergo a total of two studies. Blood draws will be necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Insulin plus sitagliptin | Active comparator | Drug: SitagliptinThe subjects continued their usual insulin regimen throughout the study. Sitagliptin was started and continued at 50 mg orally twice daily |
| Insulin plus metformin | Active comparator | Drug: MetforminThe subjects continued their usual insulin regimen throughout the study. Metformin was started at 500 mg orally daily. The dose was increased over a 2 week period up to 2,000 mg per day as tolerated. |
| Insulin plus sitagliptin and metformin | Active comparator | Drug: Sitagliptin + MetforminThe subjects continued their usual insulin regimen throughout the study. Sitagliptin was started and continued at 50 mg orally twice daily. Metformin was started at 500 mg orally daily. The dose was increased over a 2 week period up to 2,000 mg per day as tolerated. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age of 13 to 18 years
- HbA1c >7.5% but <10%
- Subjects must be on intensive insulin management
- Tanner stage greater than or equal to 4
- Must have T1DM for at least one year , T1DM defined by ADA criteria and having at least one of the following antibodies: Anti-GAD, Anti-islet, Anti-insulin
Key exclusion criteria (5 listed)
- Type 2 diabetes
- History of any other chronic condition (except hypothyroidism stable on medications)
- Actively taking medications that may affect glucose excursions (steroids or oral contraceptives)
- Evidence of anemia, clinically significant elevation of the liver enzymes (3 X normal), amylase or lipase (2 X normal), abnormal triclycerides (3 X normal), abnormal renal function test
- An unsupportive family environment and pregnant or lactating females
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 |
|---|---|---|
| SitagliptinAlso: Januviaup to 50 mg twice a day | Drug | Insulin plus sitagliptin |
| MetforminAlso: Glucophageup to 1000 mg twice a day | Drug | Insulin plus metformin |
| Sitagliptin + MetforminAlso: Sitagliptin + Metformin = Janumetup to 50/1000 mg twice a day | Drug | Insulin plus sitagliptin and metformin |
Primary outcome
To determine the glucose lowering effect of metformin and sitagliptin alone and as combination therapy when used as adjuncts to insulin in adolescents with T1DM.
Time frame: 10 - 15 weeks
Glucose concentrations and AUC glucose calculation
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 24 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Luisa M. Rodriguez, MD, MS principal investigator
Baylor College of Medicine
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 Sitagliptin, Metformin and Sitagliptin + Metformin in people with Type 1 Diabetes, run by Baylor College of Medicine 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 6 inclusion and 5 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 24 Apr 2017. 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?
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?
To determine the glucose lowering effect of metformin and sitagliptin alone and as combination therapy when used as adjuncts to insulin in adolescents with T1DM. (time frame: 10 - 15 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 24 Apr 2017.