Glycemic Holter Study (Continuous Glucose Monitoring) - (OPTIMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01193296
Recruitment Status : Completed
First Posted : September 1, 2010
Last Update Posted : May 4, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Vildagliptin Drug: Sitagliptin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Vildagliptin Drug: Vildagliptin
Active Comparator: Sitagliptin Drug: Sitagliptin

Primary Outcome Measures :
  1. Glycemic variability assessed by MAGE (Mean Amplitude of Glycemic Excursion) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Glycemic control assessed through CSGM [ Time Frame: 8 weeks ]
  2. 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 ]
  3. Unrecognized hypoglycemic periods recorded by CSGM, frequency and duration [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01193296

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
Venissieux, France
Sponsors and Collaborators

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Identifier: NCT01193296     History of Changes
Other Study ID Numbers: CLAF237AFR02
First Posted: September 1, 2010    Key Record Dates
Last Update Posted: May 4, 2012
Last Verified: May 2012

Keywords provided by Novartis:
Diabetes mellitus, vildagliptin, continuous glucose monitoring

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action