Trial Outcomes & Findings for Sitagliptin + Metformin Compared to Metformin Monotherapy and Placebo in Women With a Recent GDM (NCT NCT01856907)

NCT ID: NCT01856907

Last Updated: 2018-01-23

Results Overview

Normalization of glucose in patients with abnormal glucose levels is defined as a fasting glucose level of \<100 mg/dL and a 2-hour glucose level following a 75 gram oral glucose load of \<140 mg/dL

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 36 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2018-01-23

Participant Flow

The study was conducted from November 2014 to September 2017. Patients were recruited from the Woman's Hospital Metabolic Clinic

. 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.

Participant milestones

Measure	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
Overall Study STARTED	12	12	12
Overall Study COMPLETED	12	9	12
Overall Study NOT COMPLETED	0	3	0

Reasons for withdrawal

Measure	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
Overall Study Pregnancy	0	1	0
Overall Study Withdrawal by Subject	0	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Sitagliptin-Metformin n=12 Participants 50 mg/1000 mg BID Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication	Placebo Pill n=12 Participants 1 pill/BID for 16 weeks Placebo pill: Will evaluate effect of lifestyle and diet only	Metformin n=12 Participants 1000 mg BID Metformin: Biguanide- insulin sensitizer	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	36 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex/Gender, Customized Patients	12 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	36 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	29 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	12 participants n=5 Participants	36 participants n=4 Participants
Hyperglycemia	12 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	36 Participants n=4 Participants

PRIMARY outcome

Timeframe: 16 weeks

Normalization of glucose in patients with abnormal glucose levels is defined as a fasting glucose level of <100 mg/dL and a 2-hour glucose level following a 75 gram oral glucose load of <140 mg/dL

Outcome measures

Measure	Sitagliptin-Metformin n=12 Participants 50 mg/1000 mg twice a day (BID) Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication	Placebo Pill n=9 Participants 1 pill/ twice a day (BID) for 16 weeks Placebo pill: Will evaluate effect of lifestyle and diet only	Metformin n=12 Participants 1000 mg twice a day (BID) Metformin: Biguanide- insulin sensitizer
Normalization of Glucose Levels	9 Participants	2 Participants	4 Participants

SECONDARY outcome

Timeframe: 16 weeks

Blood glucose in the fasting state

Outcome measures

Measure	Sitagliptin-Metformin n=12 Participants 50 mg/1000 mg twice a day (BID) Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication	Placebo Pill n=9 Participants 1 pill/ twice a day (BID) for 16 weeks Placebo pill: Will evaluate effect of lifestyle and diet only	Metformin n=12 Participants 1000 mg twice a day (BID) Metformin: Biguanide- insulin sensitizer
Fasting Blood Glucose	96 mg/dL Standard Deviation 13	101 mg/dL Standard Deviation 13	93 mg/dL Standard Deviation 6

SECONDARY outcome

Timeframe: 16 weeks

The mean blood glucose is calculated by averaging the 4 blood glucose levels measure during a 75 gm oral glucose tolerance test . This involves summing the glucose levels measured at baseline, and 1/2 hour,1 hour and 2 hours after the glucose load and dividing by 4..

Outcome measures

Measure	Sitagliptin-Metformin n=12 Participants 50 mg/1000 mg twice a day (BID) Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication	Placebo Pill n=9 Participants 1 pill/ twice a day (BID) for 16 weeks Placebo pill: Will evaluate effect of lifestyle and diet only	Metformin n=12 Participants 1000 mg twice a day (BID) Metformin: Biguanide- insulin sensitizer
Mean Blood Glucose Level From the Oral Glucose Tolerance Test (OGTT)	113 mg/dL Standard Deviation 19	132 mg/dL Standard Deviation 17	143 mg/dL Standard Deviation 20

SECONDARY outcome

Timeframe: 16 weeks

Insulin resistance calculated from fasting glucose and insulin levels known as HOMA-IR

Outcome measures

Measure	Sitagliptin-Metformin n=12 Participants 50 mg/1000 mg twice a day (BID) Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication	Placebo Pill n=9 Participants 1 pill/ twice a day (BID) for 16 weeks Placebo pill: Will evaluate effect of lifestyle and diet only	Metformin n=12 Participants 1000 mg twice a day (BID) Metformin: Biguanide- insulin sensitizer
Fasting Insulin Resistance	2.4 index Standard Deviation 1.2	4.7 index Standard Deviation 3.8	2.6 index Standard Deviation 1.7

SECONDARY outcome

Timeframe: 16 weeks

Composite insulin sensitivity index calculated from from glucose and insulin levels obtained during the OGTT

Outcome measures

Measure	Sitagliptin-Metformin n=12 Participants 50 mg/1000 mg twice a day (BID) Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication	Placebo Pill n=9 Participants 1 pill/ twice a day (BID) for 16 weeks Placebo pill: Will evaluate effect of lifestyle and diet only	Metformin n=12 Participants 1000 mg twice a day (BID) Metformin: Biguanide- insulin sensitizer
Matsuda Index of Insulin Sensitivity	6.2 index Standard Deviation 3.9	5.0 index Standard Deviation 4.9	5.2 index Standard Deviation 4

SECONDARY outcome

Timeframe: 16 weeks

Measure of pancreatic beta cell compensatory action known as IS-SI

Outcome measures

Measure	Sitagliptin-Metformin n=12 Participants 50 mg/1000 mg twice a day (BID) Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication	Placebo Pill n=9 Participants 1 pill/ twice a day (BID) for 16 weeks Placebo pill: Will evaluate effect of lifestyle and diet only	Metformin n=12 Participants 1000 mg twice a day (BID) Metformin: Biguanide- insulin sensitizer
Oral Disposition Index	427 index Standard Deviation 231	194 index Standard Deviation 93	170 index Standard Deviation 109

SECONDARY outcome

Timeframe: 16 weeks

The ratio of triglyceride to HDL cholesterol is used as an indirect measure of insulin resistance

Outcome measures

Measure	Sitagliptin-Metformin n=12 Participants 50 mg/1000 mg twice a day (BID) Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication	Placebo Pill n=9 Participants 1 pill/ twice a day (BID) for 16 weeks Placebo pill: Will evaluate effect of lifestyle and diet only	Metformin n=12 Participants 1000 mg twice a day (BID) Metformin: Biguanide- insulin sensitizer
Triglyceride/HDL-Cholesterol Ratio	3.3 Ratio Standard Deviation 1.4	4.5 Ratio Standard Deviation 3.1	2.7 Ratio Standard Deviation 1.5

SECONDARY outcome

Timeframe: 16 weeks

Measure of body weight corrected by height

Outcome measures

Measure	Sitagliptin-Metformin n=12 Participants 50 mg/1000 mg twice a day (BID) Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication	Placebo Pill n=9 Participants 1 pill/ twice a day (BID) for 16 weeks Placebo pill: Will evaluate effect of lifestyle and diet only	Metformin n=12 Participants 1000 mg twice a day (BID) Metformin: Biguanide- insulin sensitizer
Body Mass Index	32.6 kg/meters^2 Standard Deviation 8	33.5 kg/meters^2 Standard Deviation 9	33.6 kg/meters^2 Standard Deviation 6

SECONDARY outcome

Timeframe: 16 weeks

Measure of central fat

Outcome measures

Measure	Sitagliptin-Metformin n=12 Participants 50 mg/1000 mg twice a day (BID) Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication	Placebo Pill n=9 Participants 1 pill/ twice a day (BID) for 16 weeks Placebo pill: Will evaluate effect of lifestyle and diet only	Metformin n=12 Participants 1000 mg twice a day (BID) Metformin: Biguanide- insulin sensitizer
Waist Circumference	90 centimeters Standard Deviation 14	93 centimeters Standard Deviation 17	93 centimeters Standard Deviation 13

SECONDARY outcome

Timeframe: 16 weeks

Measure of central obesity adjusted for stature

Outcome measures

Measure	Sitagliptin-Metformin n=12 Participants 50 mg/1000 mg twice a day (BID) Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication	Placebo Pill n=9 Participants 1 pill/ twice a day (BID) for 16 weeks Placebo pill: Will evaluate effect of lifestyle and diet only	Metformin n=12 Participants 1000 mg twice a day (BID) Metformin: Biguanide- insulin sensitizer
Waist-to-Height Ratio	.54 Ratio Standard Deviation .09	.57 Ratio Standard Deviation .1	.58 Ratio Standard Deviation .07

OTHER_PRE_SPECIFIED outcome

Timeframe: 16 weeks

Number of patients with no clinically significant changes in liver enzymes-measure of liver enzymes was a study safety endpoint

Outcome measures

Measure	Sitagliptin-Metformin n=12 Participants 50 mg/1000 mg twice a day (BID) Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication	Placebo Pill n=9 Participants 1 pill/ twice a day (BID) for 16 weeks Placebo pill: Will evaluate effect of lifestyle and diet only	Metformin n=12 Participants 1000 mg twice a day (BID) Metformin: Biguanide- insulin sensitizer
Liver Enzymes as Safety Measure	0 Participants	0 Participants	0 Participants

Adverse Events

Sitagliptin-Metformin

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo Pill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Metformin

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sitagliptin-Metformin n=12 participants at risk 50 mg/1000 mg BID Sitagliptin-Metformin: Experimental -DPP-4 inhibitor- oral medication	Placebo Pill n=12 participants at risk 1 pill/BID for 16 weeks Placebo pill: Will evaluate effect of lifestyle and diet only	Metformin n=12 participants at risk 1000 mg BID Metformin: Biguanide- insulin sensitizer
Gastrointestinal disorders Diarrhea	25.0% 3/12 • Number of events 4 • 16 weeks	0.00% 0/12 • 16 weeks	25.0% 3/12 • Number of events 4 • 16 weeks

Additional Information

Dr Karen Elkind-Hirsch

Woman's Hospital

Phone: 225-231-5278

Email: karen.elkind-hirsch@womans.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place