Clinical trial NCT01193296: Glycemic Holter Study (Continuous Glucose Monitoring) -
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes mellitus, vildagliptin, continuous glucose monitoring
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-09-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Glycemic variability assessed by MAGE (Mean Amplitude of Glycemic Excursion)
timeFrame: 8 weeks
Secondary outcomes:
measure: Glycemic control assessed through CSGM
timeFrame: 8 weeks
measure: 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
timeFrame: 8 weeks
measure: Unrecognized hypoglycemic periods recorded by CSGM, frequency and duration
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bondy
country: France
facility: Investigative Site
city: Corbeil
country: France
facility: Investigative Site
city: Marseille
country: France
facility: Investigative Site
city: Nancy
country: France
facility: Investigative Site
city: Paris
country: France
facility: Investigative Site
city: Toulouse
country: France
facility: Investigative Site
city: Venissieux
country: France
facility: Investigative Site
Study officials:
References:
citation: 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.
citation: Monnier 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.