NCT01195090

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes

Timeline
Completed

Started Oct 2009

Typical duration for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 3, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
6 months until next milestone

Results Posted

Study results publicly available

October 10, 2012

Completed
Last Updated

October 10, 2012

Status Verified

September 1, 2012

Enrollment Period

2 years

First QC Date

September 2, 2010

Results QC Date

April 18, 2012

Last Update Submit

September 9, 2012

Conditions

Type 2 Diabetes

Keywords

sitagliptinpioglitazonetype 2 diabetes

Outcome Measures

Primary Outcomes (3)

  • Mean Change in Glycosylated Hemoglobin (A1C)

    A1C change from baseline to 24 weeks

    24 weeks

  • Baseline A1C

    baseline A1C

    Baseline

  • The Percentages of Patient Achieving an A1C <7%

    The percentages of patient achieving an A1C \<7% at endpoint

    24 weeks

Secondary Outcomes (24)

  • Changes in Fasting Plasma Glucose

    24 weeks

  • Changes in High Sensitive C-reactive Protein

    24 weeks

  • Changes in Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    24 weeks

  • Body Weight Change

    24 weeks

  • Percentages of Patients With Total Adverse Events (AE)

    24 weeks

  • +19 more secondary outcomes

Study Arms (2)

sitagliptin

ACTIVE COMPARATOR

add sitagliptin100mg/d to pre-study OADs

Drug: Sitagliptin

pioglitazone

ACTIVE COMPARATOR

add pioglitazone 30mg/d to pre-study OADs

Drug: pioglitazone

Interventions

SitagliptinDRUG

add sitagliptin100mg/d to pre-study OADs

Also known as: Januvia
sitagliptin
pioglitazoneDRUG

add pioglitazone 30mg/d to pre-study OADs

Also known as: actos
pioglitazone

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Taipei, Taipei, 10449, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin PhosphatePioglitazone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesThiazolidinedionesThiazolesSulfur CompoundsOrganic Chemicals

Limitations and Caveats

The reasons for withdrawal: lost to follow-up:2 in pioglitazone and 2 in sitagliptin protocol violation:4 in pioglitazone and 3 in sitagliptin edema:1 in pioglitazone, ALT \>3 times ULN:1 in pioglitazone gastrointestinal events:1 in sitagliptin

Results Point of Contact

Title
Dr. Sung-Chen Liu
Organization
Department of Internal Medicine, Mackay Memorial Hospital
pine3.tw@yahoo.com.tw
886-2-2543-3535

Study Officials

  • Sung-Chen Liu, MD

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Mackay Memorial Hospital

Study Record Dates

First Submitted

September 2, 2010

First Posted

September 3, 2010

Study Start

October 1, 2009

Primary Completion

October 1, 2011

Study Completion

April 1, 2012

Last Updated

October 10, 2012

Results First Posted

October 10, 2012

Record last verified: 2012-09

Locations

TW(1)