Type 2 Diabetes MellitusPhase 4OPTIMANCT01193296
Glycemic Holter Study (Continuous Glucose Monitoring) -
A Phase 4 study testing Vildagliptin and Sitagliptin in people with Type 2 Diabetes Mellitus, run by Novartis at 7 sites in France.
Trial summary
The study will assess glycemic variability and optimized glycemic control in T2DM patients treated with a DPP-4 inhibitor as add-on therapy to metformin. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Vildagliptin and Sitagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 7 sitesFrance
- Study dates
- Jun 2010to Jun 2011
- 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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes Mellitus (DM) willing to perform SMBG at least 6 times daily to use the MiniMed CGMS for up to 3 consecutive days on 2 occasions.
- HbA1c: 6.5 to 9% with metformin monotherapy for a least 3 months
Who cannot join
- Age >= 80 years
- BMI <= 22 and >=40 kg/m2
- Secondary T2 DM
- Hepatic failure, ASAT/ALAT>3 ULN, and moderate/severe renal failure (CI < 50 ml/min) CHF III \& IV
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Investigative Site
Bondy
Investigative Site
Corbeil
Investigative Site
Marseille
Investigative Site
Nancy
Investigative Site
Paris
Investigative Site
Toulouse
Investigative Site
Vénissieux
About this study
Official title: Prospective, Randomized, Open-label Study With Blinded Endpoint (PROBE Design) to Compare the 72 hr Glycemic Profiles Obtained by Continuous Subcutaneous Glucose Monitoring (CSGM) in Type 2 Diabetic Patients at Baseline With Metformin Monotherapy and After an 8-week Period With the Addition of Either Vildagliptin or Sitagliptin in Patients Insufficiently Controlled by Metformin After at Least 3 Months of Monotherapy
The study will assess glycemic variability and optimized glycemic control in T2DM patients treated with a DPP-4 inhibitor as add-on therapy to metformin.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Vildagliptin, Sitagliptin
- Keywords
- Diabetes mellitus, vildagliptin, continuous glucose monitoring
- 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.
VildagliptinDrug
SitagliptinDrug
| Study group | Role | What they receive |
|---|---|---|
| Vildagliptin | Experimental | Not described Receives: Drug: Vildagliptin |
| Sitagliptin | Active comparator | Not described Receives: Drug: Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic variability assessed by MAGE (Mean Amplitude of Glycemic Excursion)
Measured: 8 weeks
Secondary outcomes (3)
Glycemic control assessed through CSGM
Measured: 8 weeks
Glycemic control assessed by A1C, FPG, PPG and the mean of 6 points self-monitoring of blood glucose (SMBG) at baseline and after 8 weeks
Measured: 8 weeks
Unrecognized hypoglycemic periods recorded by CSGM, frequency and duration
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193296
- Sponsor's protocol ID
- CLAF237AFR02
- Acronym
- OPTIMA
- Status last verified
- May 2012
- First submitted
- 31 Aug 2010
- Last updated
- 4 May 2012
- Results posted
- No
Publications
Guerci B, Monnier L, Serusclat P, Petit C, Valensi P, Huet D, Raccah D, Colette C, Quere S, Dejager S. Continuous glucose profiles with vildagliptin versus sitagliptin in add-on to metformin: results from the randomized Optima study. Diabetes Metab. 2012 Oct;38(4):359-66. doi: 10.1016/j.diabet.2012.06.001. Epub 2012 Jul 17.
PubMed 22809630Monnier L, Colette C, Comenducci A, Vallee D, Dejager S. Add-on therapies to metformin in type 2 diabetes: what modulates the respective decrements in postprandial and basal glucose? Diabetes Technol Ther. 2012 Oct;14(10):943-50. doi: 10.1089/dia.2012.0045. Epub 2012 Jul 9.
PubMed 22775317
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Open-label Study With Blinded Endpoint (PROBE Design) to Compare the 72 hr Glycemic Profiles Obtained by Continuous Subcutaneous Glucose Monitoring (CSGM) in Type 2 Diabetic Patients at Baseline With Metformin Monotherapy and After an 8-week Period With the Addition of Either Vildagliptin or Sitagliptin in Patients Insufficiently Controlled by Metformin After at Least 3 Months of Monotherapy
- ClinicalTrials.gov ID
- NCT01193296
- Acronym / sponsor ID
- OPTIMA / CLAF237AFR02
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes mellitus, vildagliptin, continuous glucose monitoring
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 1 Sep 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 study will assess glycemic variability and optimized glycemic control in T2DM patients treated with a DPP-4 inhibitor as add-on therapy to metformin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vildagliptin | Experimental | Drug: Vildagliptin |
| Sitagliptin | Active comparator | Drug: Sitagliptin |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 Diabetes Mellitus (DM) willing to perform SMBG at least 6 times daily to use the MiniMed CGMS for up to 3 consecutive days on 2 occasions.
- HbA1c: 6.5 to 9% with metformin monotherapy for a least 3 months
Key exclusion criteria (5 listed)
- Age >= 80 years
- BMI <= 22 and >=40 kg/m2
- Secondary T2 DM
- Hepatic failure, ASAT/ALAT>3 ULN, and moderate/severe renal failure (CI < 50 ml/min) CHF III \& IV
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| Vildagliptin | Drug | Vildagliptin |
| Sitagliptin | Drug | Sitagliptin |
Primary outcome
Glycemic variability assessed by MAGE (Mean Amplitude of Glycemic Excursion)
Time frame: 8 weeks
3 secondary outcomes
Glycemic control assessed through CSGM
Time frame: 8 weeks
Glycemic control assessed by A1C, FPG, PPG and the mean of 6 points self-monitoring of blood glucose (SMBG) at baseline and after 8 weeks
Time frame: 8 weeks
Unrecognized hypoglycemic periods recorded by CSGM, frequency and duration
Time frame: 8 weeks
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 4 May 2012.
- Derived from this study: PubMed 22809630Guerci B, Monnier L, Serusclat P, Petit C, Valensi P, Huet D, Raccah D, Colette C, Quere S, Dejager S. Continuous glucose profiles with vildagliptin versus sitagliptin in add-on to metformin: results from the randomized Optima study. Diabetes Metab. 2012 Oct;38(4):359-66. doi: 10.1016/j.diabet.2012.06.001. Epub 2012 Jul 17.
- Derived from this study: PubMed 22775317Monnier L, Colette C, Comenducci A, Vallee D, Dejager S. Add-on therapies to metformin in type 2 diabetes: what modulates the respective decrements in postprandial and basal glucose? Diabetes Technol Ther. 2012 Oct;14(10):943-50. doi: 10.1089/dia.2012.0045. Epub 2012 Jul 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 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 Vildagliptin and Sitagliptin in people with Type 2 Diabetes Mellitus, run by Novartis at 7 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 2 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 4 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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?
Glycemic variability assessed by MAGE (Mean Amplitude of Glycemic Excursion) (time frame: 8 weeks). 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 NCT01193296, which also lists 2 linked publications.
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 4 May 2012.