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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01193296
First received: August 31, 2010
Last updated: May 3, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
 Drug: Vildagliptin
Drug: Sitagliptin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Glycemic variability assessed by MAGE (Mean Amplitude of Glycemic Excursion) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glycemic control assessed through CSGM [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Unrecognized hypoglycemic periods recorded by CSGM, frequency and duration [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: June 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vildagliptin Drug: Vildagliptin
Active Comparator: Sitagliptin Drug: Sitagliptin

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193296

Locations
France
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
Novartis
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01193296     History of Changes
Other Study ID Numbers: CLAF237AFR02
Study First Received: August 31, 2010
Last Updated: May 3, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
European Union: European Medicines Agency

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
Vildagliptin
Sitagliptin
 Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013