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Glycemic Holter Study (Continuous Glucose Monitoring) - (OPTIMA) Phase 4 36

Completed
Clinical Trial NCT01193296 (OPTIMA) was designed to study Treatment for Type 2 Diabetes Mellitus. This was a Phase 4 interventional study that is now completed. The study started on 1 June 2010, with plans to enroll 36 participants. Led by Novartis, the expected completion date was 1 June 2011. The latest data from ClinicalTrials.gov was last updated on 4 May 2012.
Brief 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.
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

Conditions
Type 2 Diabetes Mellitus
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • OPTIMA
  • CLAF237AFR02
NCT ID Number
NCT01193296
Start Date (Actual)
2010-06
Last Update Posted
2012-05-04
Completion Date (Estimated)
2011-06
Enrollment (Estimated)
36
Study Type
Interventional
PHASE
Phase 4
Status
Completed
Keywords
Diabetes mellitus, vildagliptin, continuous glucose monitoring
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalVildagliptin
Vildagliptin
Active ComparatorSitagliptin
Sitagliptin
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Glycemic variability assessed by MAGE (Mean Amplitude of Glycemic Excursion)
8 weeks
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Glycemic control assessed through CSGM
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
8 weeks
Unrecognized hypoglycemic periods recorded by CSGM, frequency and duration
8 weeks
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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

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No contact data.
7 Study Locations in 1 Countries
Investigative Site, Bondy, France
Investigative Site, Corbeil, France
Investigative Site, Marseille, France
Investigative Site, Nancy, France
Investigative Site, Paris, France
Investigative Site, Toulouse, France
Investigative Site, Vénissieux, France