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Sitagliptin + Metformin Compared to Metformin Monotherapy and Placebo in Women With a Recent GDM

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ClinicalTrials.gov Identifier: NCT01856907
Recruitment Status : Completed
First Posted : May 20, 2013
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Karen Elkind-Hirsch, Woman's

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition: Disorder of Glucose Regulation
Interventions: Drug: Sitagliptin-Metformin
Drug: Metformin
Drug: Placebo pill

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted from November 2014 to September 2017. Patients were recruited from the Woman's Hospital Metabolic Clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
. Patients were eligible for randomization if they had impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or both (IFG/IGT) by OGTT. Patients with diabetes or normal glucose tolerance were excluded.

Reporting Groups
  Description
Sitagliptin-Metformin

50 mg/1000 mg BID

Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication

Placebo Pill

1 pill/BID for 16 weeks

Placebo pill: Will evaluate effect of lifestyle and diet only

Metformin

1000 mg BID

Metformin: Biguanide- insulin sensitizer


Participant Flow:   Overall Study
    Sitagliptin-Metformin   Placebo Pill   Metformin
STARTED   12   12   12 
COMPLETED   12   9   12 
NOT COMPLETED   0   3   0 
Pregnancy                0                1                0 
Pregnancy                0                1                0 
Withdrawal by Subject                0                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sitagliptin-Metformin

50 mg/1000 mg BID

Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication

Placebo Pill

1 pill/BID for 16 weeks

Placebo pill: Will evaluate effect of lifestyle and diet only

Metformin

1000 mg BID

Metformin: Biguanide- insulin sensitizer

Total Total of all reporting groups

Baseline Measures
   Sitagliptin-Metformin   Placebo Pill   Metformin   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   12   12   36 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      12 100.0%      12 100.0%      12 100.0%      36 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Sex/Gender, Customized [1] 
[Units: Participants]
Count of Participants
       
Patients   12   12   12   36 
[1] Postpartum previous GDM females
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2  16.7%      3  25.0%      2  16.7%      7  19.4% 
White      10  83.3%      9  75.0%      10  83.3%      29  80.6% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
       
United States   12   12   12   36 
Hyperglycemia 
[Units: Participants]
Count of Participants
 12   12   12   36 


  Outcome Measures

1.  Primary:   Normalization of Glucose Levels   [ Time Frame: 16 weeks ]

2.  Secondary:   Fasting Blood Glucose   [ Time Frame: 16 weeks ]

3.  Secondary:   Mean Blood Glucose Level From the Oral Glucose Tolerance Test (OGTT)   [ Time Frame: 16 weeks ]

4.  Secondary:   Fasting Insulin Resistance   [ Time Frame: 16 weeks ]

5.  Secondary:   Matsuda Index of Insulin Sensitivity   [ Time Frame: 16 weeks ]

6.  Secondary:   Oral Disposition Index   [ Time Frame: 16 weeks ]

7.  Secondary:   Triglyceride/HDL-Cholesterol Ratio   [ Time Frame: 16 weeks ]

8.  Secondary:   Body Mass Index   [ Time Frame: 16 weeks ]

9.  Secondary:   Waist Circumference   [ Time Frame: 16 weeks ]

10.  Secondary:   Waist-to-Height Ratio   [ Time Frame: 16 weeks ]

11.  Other Pre-specified:   Liver Enzymes as Safety Measure   [ Time Frame: 16 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Important limitations of the present study were the small number of patients in the treatment groups and the short interval (16 weeks) of drug treatment. Second, surrogate measures were used to estimate insulin sensitivity and secretion.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Karen Elkind-Hirsch
Organization: Woman's Hospital
phone: 225-231-5278
e-mail: karen.elkind-hirsch@womans.org



Responsible Party: Karen Elkind-Hirsch, Woman's
ClinicalTrials.gov Identifier: NCT01856907     History of Changes
Other Study ID Numbers: RP13-009
First Submitted: May 14, 2013
First Posted: May 20, 2013
Results First Submitted: September 13, 2017
Results First Posted: January 23, 2018
Last Update Posted: January 23, 2018