Glycemic Holter Study (Continuous Glucose Monitoring) -

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vildagliptin

Group Type EXPERIMENTAL

Vildagliptin

Intervention Type DRUG

Sitagliptin

Group Type ACTIVE_COMPARATOR

Sitagliptin

Intervention Type DRUG

Interventions

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Vildagliptin

Intervention Type DRUG

Sitagliptin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No