Time Required for 50% of Radioactivity To Be Emptied From the Stomach by Scintigraphy
| Group | Value (hours) |
|---|---|
| Placebo | 1.44 |
| LY2189265 | 1.72 |
Trial · Interventional
CompletedPhase 1Results postedRegistry dataUnited Kingdom
1 trial · 1 completed · 1 with posted results
A Study to Evaluate the Effect of LY2189265 on the Speed at Which Food and Drink Leaves the Stomach in Patients With Type 2 Diabetes Mellitus
NCT01215968Sept 2010 to Jul 2011
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The primary purpose of this Study is to help answer the following research question(s). * How does LY2189265 affect gastric emptying (the speed at which food and drink leaves the stomach) in patients with Type 2 diabetes? * How does LY2189265 affect how the body handles metformin (a drug used to treat Type 2 diabetes)? * Is LY2189265 safe and are any side effects associated with it? The study will be participant-blind in Week 1, and participant- and investigator-blind from Week 2 through Week 5. Each participant will receive placebo on Week 1 and once-weekly doses of LY2189265 or Placebo on Weeks 2 to 5. Participants taking metformin for the treatment of Type 2 Diabetes Mellitus (T2DM) will continue taking metformin as part of the study.
Placebo comparator
Placebo
Each participant will receive placebo on Week 1. Participants randomized to placebo will receive once-weekly doses of placebo on Weeks 2 to 5. Placebo will be administered by single subcutaneous injection into the skin of the abdominal wall. Participants regularly taking metformin will continue their normal dosing regimen throughout the study.
Experimental
LY2189265
Participants randomized to LY2189265 will receive once-weekly doses of LY2189265 on Weeks 2 to 5. 1.5 milligram (mg) LY2189265 will be administered by single subcutaneous injection into the skin of the abdominal wall. Participants regularly taking metformin will continue their normal dosing regimen throughout the study.
Outcomes the sponsor listed as primary.
Time Required for 50% of Radioactivity To Be Emptied From the Stomach by Scintigraphy
Time frame · Days 3, 10,17, 24 and 31
After at least 8 hours fasting, participants received a radiolabeled breakfast containing technetium-99m-tin colloid (99mTc-tin colloid). After which serial anterior and posterior scintigraphy images were taken. Data presented are the time required for 50% of radioactivity to be emptied from stomach. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for weeks.
Area Under the Curve (AUC) of Metformin
Time frame · Days 3, 17 and 31
Metformin was used as a secondary marker in the study to correlate the effect of LY2189265 on gastric emptying to the pharmacokinetics (PK) (measured as AUC) of concomitant medications. Participants taking metformin for treatment of Type 2 Diabetes Mellitus (T2DM) underwent PK assessments for metformin in parallel to their scintigraphy assessments for gastric emptying. AUC of metformin was calculated during one dosing interval.
Maximum Concentration (Cmax) of Metformin
Time frame · Days 3, 17 and 31
Metformin was used as a secondary marker in the study to correlate the effect of LY2189265 on gastric emptying to the pharmacokinetics (PK) (measured as Cmax) of concomitant medications. Participants taking metformin for treatment of Type 2 Diabetes Mellitus (T2DM) underwent PK assessments for metformin in parallel to their scintigraphy assessments for gastric emptying.
Time to Maximum Concentration (Tmax) of Metformin
Time frame · Days 3, 17 and 31
Metformin was used as a secondary marker in the study to correlate the effect of LY2189265 on gastric emptying to the pharmacokinetics (PK) (measured as Tmax) of concomitant medications. Participants taking metformin for treatment of Type 2 Diabetes Mellitus (T2DM) underwent PK assessments for metformin in parallel to their scintigraphy assessments for gastric emptying.
Number of Participants With Clinically Significant Effects
Time frame · Baseline through 5 weeks
Adverse events (AEs) were considered clinically significant effects. A summary of serious adverse events (SAEs) and other nonserious AEs are located in the Reported Adverse Event section.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (hours) |
|---|---|
| Placebo | 1.44 |
| LY2189265 | 1.72 |
| Group | Value (nanograms*hour/milliliter (ng*h/mL)) | Spread |
|---|---|---|
| Placebo | 13600 | 49 |
| LY2189265 | 13700 | 40 |
| Group | Value (nanograms/milliliter (ng/mL)) | Spread |
|---|---|---|
| Placebo | 1610 | 48 |
| LY2189265 | 1690 | 47 |
| Group | Value (hour) |
|---|---|
| Placebo | 1.00 |
| LY2189265 | 2.02 |
| Group | Value (participants) |
|---|---|
| Placebo | 0 |
| Placebo (Week 1) | 0 |
| LY2189265 | 0 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| PlaceboParticipants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5. | – | 0 / 13 | 7 / 13 |
| Placebo (Week 1)Participants received placebo on Week 1 and went on to receive once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5. | – | 0 / 25 | 11 / 25 |
| LY2189265Participants received placebo on Week 1 and once-weekly doses of 1.5 mg LY2189265 on Weeks 2 to 5. | – | 0 / 24 | 20 / 24 |
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