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Adding Sitagliptin or Pioglitazone to Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin and Sulfonylurea

NCT ID: NCT01195090

Last Updated: 2012-10-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-04-30

Brief Summary

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This 24-weeks study will to compare the glycemic efficacy and safety of sitagliptin with pioglitazone in patients with type 2 diabetes who had inadequate glycemic control despite dual therapy with metformin and a sulfonylurea.

Detailed Description

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This is a prospective, open-label, randomized, parallel, 24-week study. Inclusion criteria: type 2 diabetes patients who were treated with stable doses of sulfonylurea and metformin to their half maximally dose (sulfonylureas \> half maximal dose, and metformin \> 1500 mg/d) for \> 10 weeks. \> 20 years old; A1C:\> 7.0 % and \< 11% Exclusion criteria: insulin use within 12 weeks of the screening visit, any contraindications for use of sitagliptin or pioglitazone, impaired renal function (serum creatinine \> 1.4 mg/dl), alanine aminotransferase (ALT) or aspartate aminotransferase levels (AST) \> 2.5 times the upper limit of normal (ULN), current or prepare to pregnancy and lactation.

Primary Purpose:

compare the change in hemoglobin A1c and the proportion of patients achieving A1C \< 7% between the 2 groups

Secondary Purposes:

1. Changes in fasting plasma glucose, high sensitive C-reactive protein (hsCRP)
2. Homeostasis model assessment-β cell function(HOMA-β) will be calculated to assess changes in β-cell function and HOMA-insulin resistance(HOMA-IR)to assess changes in insulin resistance
3. Body weight change, proportion of side effects

Conditions

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Type 2 Diabetes

Keywords

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sitagliptin pioglitazone type 2 diabetes

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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sitagliptin

add sitagliptin100mg/d to pre-study OADs

Group Type ACTIVE_COMPARATOR

Sitagliptin

Intervention Type DRUG

add sitagliptin100mg/d to pre-study OADs

pioglitazone

add pioglitazone 30mg/d to pre-study OADs

Group Type ACTIVE_COMPARATOR

pioglitazone

Intervention Type DRUG

add pioglitazone 30mg/d to pre-study OADs

Interventions

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Sitagliptin

add sitagliptin100mg/d to pre-study OADs

Intervention Type DRUG

pioglitazone

add pioglitazone 30mg/d to pre-study OADs

Intervention Type DRUG

Other Intervention Names

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Januvia actos

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes patients who were treated with stable doses of sulfonylurea and metformin to their half maximally dose (sulfonylureas \> half maximal dose, and metformin \> 1500 mg/d) for \> 10 weeks
* \> 20 years old
* A1C: \> 7.0 % and \< 11%

Exclusion Criteria

* Insulin use within 12 weeks of the screening visit
* Any contraindications for use of sitagliptin or pioglitazone, impaired renal function (serum creatinine \> 1.4 mg/dl), alanine aminotransferase or aspartate aminotransferase levels \> 2.5 times the upper limit of normal
* Current or prepare to pregnancy and lactation
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mackay Memorial Hospital

OTHER

Sponsor Role collaborator

Sung-Chen Liu

OTHER

Sponsor Role lead

Responsible Party

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Sung-Chen Liu

Mackay Memorial Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sung-Chen Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital

Locations

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Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital

Taipei, Taipei, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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09MMHIS047

Identifier Type: -

Identifier Source: org_study_id