Glycemic Holter Study (Continuous Glucose Monitoring) -

Type 2 Diabetes Mellitus Clinical Trial

— OPTIMA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01193296
• Other study ID #: CLAF237AFR02
• Status: Completed
• Phase: Phase 4
• First received: August 31, 2010
• Last updated: May 3, 2012
• Start date: June 2010
• Est. completion date: June 2011

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)European Union: European Medicines Agency
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Vildagliptin

• Sitagliptin

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic variability assessed by MAGE (Mean Amplitude of Glycemic Excursion)		8 weeks	No
Secondary	Glycemic control assessed through CSGM		8 weeks	No
Secondary	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	No
Secondary	Unrecognized hypoglycemic periods recorded by CSGM, frequency and duration		8 weeks	Yes