A Phase 4 interventional study of Sitagliptin-Metformin and Metformin in Disorder of Glucose Regulation, sponsored by Woman's. Completed at 1 site in United States. Open to female participants aged 18 Years to 42 Years. Per ClinicalTrials.gov, last updated 2018-01-23.
Sponsored by Woman's · Phase 4, Interventional, and Treatment
Gestational diabetes mellitus (GDM) is defined as "any degree of glucose intolerance with onset or first recognition during pregnancy." GDM is one of the most frequent metabolic disorders occurring during pregnancy. Approximately 7% of all pregnancies in the United States are complicated by gestational diabetes resulting in more than 200,000 cases annually. There is epidemiologic evidence associating GDM with insulin resistance, glucose intolerance, and type 2 diabetes (DM2). Among all the risk factors of diabetes mellitus, the experience of gestational diabetes is the strongest one. Systematic reviews of older studies conclude that 35-60% women with gestational diabetes will develop type 2 diabetes at rates much greater than control groups who did not have glucose intolerance during pregnancy. Studies are needed for optimal postpartum and long-term health of women who have had GDM. Recent evidence suggests that incretin-based therapies may be useful for the treatment of DM2 because continuous administration of glucagon-like peptide 1 (GLP-1) produces substantial improvements in glucose control and ß-cell function in subjects with DM2. Inhibition of dipeptidyl peptidase-4 (DPP-4) increases the concentration of GLP-1 and may potentially delay disease progression in GDM considering the ß-cell function improvement in DM2 and ß-cell mass shown to increase in animal models. This study will examine if combination sitagliptin (a DPP-4 inhibitor)-plus metformin is more effective than metformin alone or placebo in improving metabolic parameters, specifically the impact on β-cell function, in prior GDM women with glucose abnormalities.
Gestational diabetes mellitus (GDM) is defined as "any degree of glucose intolerance with onset or first recognition during pregnancy." GDM is one of the most frequent metabolic disorders occurring during pregnancy. Approximately 7% of all pregnancies in the United States are complicated by gestational diabetes resulting in more than 200,000 cases annually. There is epidemiologic evidence associating GDM with insulin resistance, glucose intolerance, and type 2 diabetes (DM2). Among all the risk factors of diabetes mellitus, the experience of gestational diabetes is the strongest one.
Gestational diabetes is often the culmination of years of unrecognized and unmodified diabetes risk factors that lead to overt and occult clinical manifestations during pregnancy. Systematic reviews of older studies conclude that 35-60% women with gestational diabetes will develop type 2 diabetes at rates much greater than control groups who did not have glucose intolerance during pregnancy. The higher rates were in studies of particular ethnic groups in the U.S. Presently, in the literature, there are described new, more efficient methods of diabetes prevention in groups with a high risk of this disorder, which involve both, lifestyle modification and pharmacological therapies. Lifestyle intervention was found to reduce the incidence of type 2 diabetes by 58% and metformin by 31% as compared with placebo. Studies are needed for optimal postpartum and long-term health of women who have had GDM. Considerable recent evidence suggests that incretin-based therapies may be useful for the treatment of DM2 because continuous administration of glucagon-like peptide 1 (GLP-1) produces substantial improvements in glucose control and ß-cell function in subjects with type 2 diabetes. Inhibition of dipeptidyl peptidase-4 (DPP-4) increases the concentration of GLP-1 and may potentially delay disease progression in GDM considering the ß-cell function improvement in DM2 and ß-cell mass shown to increase in animal models. This study will examine if combination sitagliptin-plus metformin is more effective than metformin alone or placebo in improving metabolic parameters, specifically the impact on β-cell function, in at-risk women with a recent history of GDM.
Woman's is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
50 mg/1000 mg twice a day (BID)
Drug: Sitagliptin-Metformin
1 pill/BID for 16 weeks
Drug: Placebo pill
1000 mg BID
Drug: Metformin
Experimental -dipeptidyl peptidase-4 (DPP-4) inhibitor- oral medication
Also known as: Janumet
Biguanide- insulin sensitizer
Also known as: Glucophage
Will evaluate effect of lifestyle and diet only
Also known as: placebo control
Normalization of Glucose Levels
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
Time frame: 16 weeks
Fasting Blood Glucose
Blood glucose in the fasting state
Time frame: 16 weeks
Mean Blood Glucose Level From the Oral Glucose Tolerance Test (OGTT)
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..
Time frame: 16 weeks
Fasting Insulin Resistance
Insulin resistance calculated from fasting glucose and insulin levels known as HOMA-IR
Time frame: 16 weeks
Matsuda Index of Insulin Sensitivity
Composite insulin sensitivity index calculated from from glucose and insulin levels obtained during the OGTT
Time frame: 16 weeks
Oral Disposition Index
Measure of pancreatic beta cell compensatory action known as IS-SI
Time frame: 16 weeks
Triglyceride/HDL-Cholesterol Ratio
The ratio of triglyceride to HDL cholesterol is used as an indirect measure of insulin resistance
Time frame: 16 weeks
Body Mass Index
Measure of body weight corrected by height
Time frame: 16 weeks
Waist Circumference
Measure of central fat
Time frame: 16 weeks
Waist-to-Height Ratio
Measure of central obesity adjusted for stature
Time frame: 16 weeks
Liver Enzymes as Safety Measure
Number of patients with no clinically significant changes in liver enzymes-measure of liver enzymes was a study safety endpoint
Time frame: 16 weeks
The study was conducted from November 2014 to September 2017. Patients were recruited from the Woman's Hospital Metabolic Clinic
| Milestone | Sitagliptin-Metformin | Placebo Pill | Metformin |
|---|---|---|---|
| Started | 12 | 12 | 12 |
| Completed | 12 | 9 | 12 |
| Not completed | 0 | 3 | 0 |
| Withdrew: Pregnancy | 0 | 1 | 0 |
| Withdrew: Pregnancy | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 |
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
| Participants | Sitagliptin-Metformin | Placebo Pill | Metformin |
|---|---|---|---|
| Normalization of Glucose Levels | 9 | 2 | 4 |
Blood glucose in the fasting state
| mg/dL | Sitagliptin-Metformin | Placebo Pill | Metformin |
|---|---|---|---|
| Fasting Blood Glucose | 96 ± 13 | 101 ± 13 | 93 ± 6 |
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..
| mg/dL | Sitagliptin-Metformin | Placebo Pill | Metformin |
|---|---|---|---|
| Mean Blood Glucose Level From the Oral Glucose Tolerance Test (OGTT) | 113 ± 19 | 132 ± 17 | 143 ± 20 |
Insulin resistance calculated from fasting glucose and insulin levels known as HOMA-IR
| index | Sitagliptin-Metformin | Placebo Pill | Metformin |
|---|---|---|---|
| Fasting Insulin Resistance | 2.4 ± 1.2 | 4.7 ± 3.8 | 2.6 ± 1.7 |
Composite insulin sensitivity index calculated from from glucose and insulin levels obtained during the OGTT
| index | Sitagliptin-Metformin | Placebo Pill | Metformin |
|---|---|---|---|
| Matsuda Index of Insulin Sensitivity | 6.2 ± 3.9 | 5.0 ± 4.9 | 5.2 ± 4 |
Measure of pancreatic beta cell compensatory action known as IS-SI
| index | Sitagliptin-Metformin | Placebo Pill | Metformin |
|---|---|---|---|
| Oral Disposition Index | 427 ± 231 | 194 ± 93 | 170 ± 109 |
The ratio of triglyceride to HDL cholesterol is used as an indirect measure of insulin resistance
| Ratio | Sitagliptin-Metformin | Placebo Pill | Metformin |
|---|---|---|---|
| Triglyceride/HDL-Cholesterol Ratio | 3.3 ± 1.4 | 4.5 ± 3.1 | 2.7 ± 1.5 |
Measure of body weight corrected by height
| kg/meters^2 | Sitagliptin-Metformin | Placebo Pill | Metformin |
|---|---|---|---|
| Body Mass Index | 32.6 ± 8 | 33.5 ± 9 | 33.6 ± 6 |
Measure of central fat
| centimeters | Sitagliptin-Metformin | Placebo Pill | Metformin |
|---|---|---|---|
| Waist Circumference | 90 ± 14 | 93 ± 17 | 93 ± 13 |
Measure of central obesity adjusted for stature
| Ratio | Sitagliptin-Metformin | Placebo Pill | Metformin |
|---|---|---|---|
| Waist-to-Height Ratio | .54 ± .09 | .57 ± .1 | .58 ± .07 |
Number of patients with no clinically significant changes in liver enzymes-measure of liver enzymes was a study safety endpoint
| Participants | Sitagliptin-Metformin | Placebo Pill | Metformin |
|---|---|---|---|
| Liver Enzymes as Safety Measure | 0 | 0 | 0 |
Collected over 16 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sitagliptin-Metformin | 0/12 (0%) | 0/12 (0%) | 3/12 (25%) |
| Placebo Pill | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Metformin | 0/12 (0%) | 0/12 (0%) | 3/12 (25%) |
| Event | Sitagliptin-Metformin | Placebo Pill | Metformin |
|---|---|---|---|
| DiarrheaGastrointestinal disorders | 3/12 | 0/12 | 3/12 |
| Age, Categorical(Participants) | Sitagliptin-Metformin | Placebo Pill | Metformin | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 12 | 12 | 12 | 36 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex/Gender, Customized(Participants) | Sitagliptin-Metformin | Placebo Pill | Metformin | Total |
|---|---|---|---|---|
| Patients | 12 | 12 | 12 | 36 |
| Race (NIH/OMB)(Participants) | Sitagliptin-Metformin | Placebo Pill | Metformin | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 3 | 2 | 7 |
| White | 10 | 9 | 10 | 29 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Sitagliptin-Metformin | Placebo Pill | Metformin | Total |
|---|---|---|---|---|
| United States | 12 | 12 | 12 | 36 |
| Hyperglycemia(Participants) | Sitagliptin-Metformin | Placebo Pill | Metformin | Total |
|---|---|---|---|---|
| Count of participants | 12 | 12 | 12 | 36 |
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Plan to share: No — Individual data will only be shared with participant
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