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Glycemic Holter Study (Continuous Glucose Monitoring) -

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01193296
Acronym
OPTIMA
Enrollment
36
Registered
2010-09-01
Start date
2010-06-30
Completion date
2011-06-30
Last updated
2012-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes mellitus, vildagliptin, continuous glucose monitoring

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.

Interventions

DRUGVildagliptin
DRUGSitagliptin

Sponsors

Novartis
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
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/

Design outcomes

Primary

MeasureTime frame
Glycemic variability assessed by MAGE (Mean Amplitude of Glycemic Excursion)8 weeks

Secondary

MeasureTime frame
Glycemic control assessed through CSGM8 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 weeks8 weeks
Unrecognized hypoglycemic periods recorded by CSGM, frequency and duration8 weeks

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026