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| ID | Type | Description | Link |
|---|---|---|---|
| 159 | |||
| 2010_506 |
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This study will test the hypotheses that a single dose of oxyntomodulin (OXM) will be neutral or better than placebo in lowering ambient glucose levels during a graded glucose infusion (GGI) and that a single dose of OXM will lead to a statistically significant increase in the sum of the plasma βOHB + AcAc levels compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence 1 | Experimental | OXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min - Placebo |
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| Treatment sequence 2 | Experimental | OXM 0.6 pmol/kg/min - Placebo - OXM 3.0 pmol/kg/min |
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| Treatment sequence 3 | Experimental | Placebo - OXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min |
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| Treatment sequence 4 | Experimental | OXM 3.0 pmol/kg/min - Placebo - OXM 0.6 pmol/kg/min |
|
| Treatment sequence 5 | Experimental | Placebo - OXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxyntomodulin (OXM) | Drug | Single infusion of OXM 3.0 pmol/kg/min by IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ambient plasma glucose concentration during the GGI | Last 160 minutes of OXM/placebo infusion | |
| plasma βOHB + AcAc concentrations | First 300 minutes of OXM/placebo infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29545266 | Derived | Shankar SS, Shankar RR, Mixson LA, Miller DL, Pramanik B, O'Dowd AK, Williams DM, Frederick CB, Beals CR, Stoch SA, Steinberg HO, Kelley DE. Native Oxyntomodulin Has Significant Glucoregulatory Effects Independent of Weight Loss in Obese Humans With and Without Type 2 Diabetes. Diabetes. 2018 Jun;67(6):1105-1112. doi: 10.2337/db17-1331. Epub 2018 Mar 15. | |
| 27072496 |
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|
| Treatment sequence 6 | Experimental | OXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min - Placebo |
|
| Comparator: Oxyntomodulin (OXM) | Drug | Single infusion of OXM 0.6 pmol/kg/min by IV |
|
| Comparator: Placebo [ hemaccel-containing saline] | Drug | Single Placebo infusion of hemaccel-containing saline by IV |
|
| Shankar SS, Shankar RR, Mixson LA, Miller DL, Chung C, Cilissen C, Beals CR, Stoch SA, Steinberg HO, Kelley DE. Linearity of beta-cell response across the metabolic spectrum and to pharmacology: insights from a graded glucose infusion-based investigation series. Am J Physiol Endocrinol Metab. 2016 Jun 1;310(11):E865-73. doi: 10.1152/ajpendo.00527.2015. Epub 2016 Apr 12. |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D053772 | Oxyntomodulin |
| ID | Term |
|---|---|
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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