An interventional study of Sitagliptin and Placebo in Type 2 Diabetes, sponsored by Garvan Institute of Medical Research. Completed at 1 site in Australia. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-05-13.
Sponsored by Garvan Institute of Medical Research · Not applicable, Interventional, and Treatment
This study investigated the effect of glutamine, an amino acid, glycemia, glucagon-like peptide-1 (GLP-1) and insulin in participants with type 2 diabetes.
In this study, we investigated the effect of glutamine, an amino acid, on glycemia and on GLP-1 and insulin in participants with type 2 diabetes. Preliminary data published by our group suggests that glutamine is a strong determinant of GLP-1 secretion in vitro. We tested the hypothesis that glutamine lowers postprandial blood glucose and investigated whether the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin modifies this effect.
Garvan Institute of Medical Research is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Glutamine 30 g/d (15 g with breakfast and dinner) + Sitagliptin
Drug: Sitagliptin
Glutamine 30 g/d (15 g with breakfast and dinner) + placebo
Drug: Placebo
Glutamine 30g +sitagliptin 100mg
Also known as: Januvia
Glutamine 30g +placebo (matching sitagliptin 100 mg)
Postprandial Glucose Area Under the Curve (AUC)
The area under the curve (AUC) of the postprandial glucose following a meal challenge
Time frame: 0 to 180 minutes
Fructosamine
The blood concentration of the glycemic control marker fructosamine
Time frame: 4 weeks
| Milestone | Sitagliptin, Then Placebo | Placebo, Then Sitagliptin |
|---|---|---|
| Started | 8 | 7 |
| Completed | 6 | 7 |
| Not completed | 2 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 |
| Milestone | Sitagliptin, Then Placebo | Placebo, Then Sitagliptin |
|---|---|---|
| Started | 6 | 7 |
| Completed | 6 | 7 |
| Not completed | 0 | 0 |
| Milestone | Sitagliptin, Then Placebo | Placebo, Then Sitagliptin |
|---|---|---|
| Started | 6 | 7 |
| Completed | 6 | 7 |
| Not completed | 0 | 0 |
The area under the curve (AUC) of the postprandial glucose following a meal challenge
| mmol/L*t | Glutamine+Sitagliptin | Glutamine+Placebo |
|---|---|---|
| Postprandial Glucose Area Under the Curve (AUC) | 1341 ± 180 | 1463 ± 179 |
The blood concentration of the glycemic control marker fructosamine
| micro mol per litre | Glutamine+Sitagliptin | Glutamine+Placebo |
|---|---|---|
| Fructosamine | 244 ± 41 | 240 ± 30 |
Collected over Adverse events were collected during the 4 weeks treatment with the first arm and then during the 4 weeks of treatment with the second arm. Total of 8 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sitagliptin | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Placebo | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
Participants who were randomized to receive either sitagliptin 100 mg tablet or placebo tablet (matching sitagliptin 100 mg)
| Age, Categorical(Participants) | First Received Sitagliptin, Then Placebo | First Received Placebo, Then Sitagliptin | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 3 | 6 |
| >=65 years | 3 | 4 | 7 |
| Age, Continuous(years) | First Received Sitagliptin, Then Placebo | First Received Placebo, Then Sitagliptin | Total |
|---|---|---|---|
| Mean | 64 ± 8 | 65 ± 5 | 65 ± 6 |
| Sex: Female, Male(Participants) | First Received Sitagliptin, Then Placebo | First Received Placebo, Then Sitagliptin | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 4 | 5 | 9 |
| Region of Enrollment(participants) | First Received Sitagliptin, Then Placebo | First Received Placebo, Then Sitagliptin | Total |
|---|---|---|---|
| Australia | 6 | 7 | 13 |
Plan to share: No
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Garvan Institute of Medical Research