Primary outcomeMean· Baseline (Day 1), Day 2
Pharmacodynamics: Change From Baseline to Day 2 in 24-hour Insulin Dose
| Group | Value (insulin units) | Spread |
|---|---|---|
| 100 mg LY2409021 | 1.85 | 7.15 |
| 300 mg LY2409021 | 0.80 | 9.63 |
| Placebo | 7.69 | 2.99 |
Trial · Interventional
CompletedPhase 1Results postedRegistry dataStudy of LY2409021 in Participants With Type 1 Diabetes
NCTNCT01640834 (opens ClinicalTrials.gov in a new tab)Other id14576Other idI1R-MC-GLBROther id2011-006178-19
Overview
- Status
- Completed
- Phase
- Phase 1
- Enrollment
- 20 participants (actual)
- Sponsor
- Eli Lilly and Company · Industry
- Design
- Randomized · Double masking
- Countries
1 country
Germany
- Start
- Jul 2012
- Primary completion
- Sept 2012
- Completion
- Sept 2012
- First posted
- 16 Jul 2012 (estimated)
- Last update posted
- 29 Oct 2018
- Conditions
- Diabetes Mellitus, Type 1
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20122013
- Ph 1
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study involves taking a single dose of 100 milligrams (mg) or 300 mg LY2409021 or placebo (an inactive medicine) taken as up to 3 capsules by mouth. The study will evaluate if this drug will reduce the amount of insulin a type 1 diabetic needs over 24 hours. This study includes a 7-day hospitalization period at the clinical research unit (CRU) and will involve screening within 30 days of the start of the study as well as telephone consultations within 5 days after discharge from the CRU.
Interventions
- LY2409021Drug
- PlaceboDrug
- GlucagonDrug
Arms3
Experimental
100 mg LY2409021
LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2. Placebo: 2 capsules, administered as a single oral dose on Day 2. Glucagon: 1 mg administered via intramuscular injection on Day 3.
Experimental
300 mg LY2409021
LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2. Glucagon: 1 mg administered via intramuscular injection on Day 3.
Placebo comparator
Placebo
Placebo: 3 capsules administered as a single oral dose on Day 2. Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.
Primary outcomes1
Outcomes the sponsor listed as primary.
Pharmacodynamics: Change From Baseline to Day 2 in 24-hour Insulin Dose
Time frame · Baseline (Day 1), Day 2
Registry description
The mean absolute change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported.
Secondary outcomes(7)
Pharmacodynamics: Percentage Change From Baseline to Day 2 in 24-hour Insulin
Time frame · Baseline (Day 1), Day 2
Registry description
The percentage change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported.
Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021
Time frame · Predose (Day 2) through 120 hours postdose (Day 7)
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021
Time frame · Predose (Day 2) through 120 hours postdose (Day 7)
Registry description
Exposure in terms of AUC of LY2409021 from time 0 extrapolated to infinity (AUCinf) is reported.
Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose During Drug Washout Period
Time frame · Baseline (Day 1), Day 3 up to Day 6
Registry description
Data were not captured, and, therefore, this outcome measure was not analyzed. Zero participants were included in the analysis.
Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose Needed to Maintain Euglycemia
Time frame · Baseline (Day 1), Day 3 up to Day 6
Registry description
Data were not captured, and, therefore, this outcome measure was not analyzed. Zero participants were included in the analysis.
Pharmacodynamics: Maximum Concentration (Cmax) of Glucose Concentration After 1 Milligram (mg) Glucagon Injection on Day 3
Time frame · Day 3
Registry description
The Cmax of glucose following a single dose of glucagon (1 mg) administered via an intramuscular injection is reported.
Pharmacodynamics: Area Under the Glucose Concentration Curve After a Single Dose of Glucagon on Day 3
Time frame · Day 3
Registry description
Area under the glucose concentration curve from time 0 through 2 hours after a single dose of glucagon (1 milligram) administered via an intramuscular injection is reported.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline (Day 1), Day 2
Pharmacodynamics: Percentage Change From Baseline to Day 2 in 24-hour Insulin
| Group | Value (percentage of insulin units) | Spread |
|---|---|---|
| 100 mg LY2409021 | 5.71 | 19.90 |
| 300 mg LY2409021 | 3.12 | 18.34 |
| Placebo | 22.75 | 22.20 |
Secondary outcomeGeometric mean· Predose (Day 2) through 120 hours postdose (Day 7)
Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021
| Group | Value (nanograms per milliliter) | Spread |
|---|---|---|
| 100 mg LY2409021 | 2620 | 23 |
| 300 mg LY2409021 | 6090 | 23 |
Secondary outcomeGeometric mean· Predose (Day 2) through 120 hours postdose (Day 7)
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021
| Group | Value (nanograms * hours per milliliter) | Spread |
|---|---|---|
| 100 mg LY2409021 | 209000 | 30 |
| 300 mg LY2409021 | 506000 | 22 |
Secondary outcome· Baseline (Day 1), Day 3 up to Day 6
Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose During Drug Washout Period
| Group | Value |
|---|---|
| 100 mg LY2409021 | not posted |
| 300 mg LY2409021 | not posted |
| Placebo | not posted |
Secondary outcome· Baseline (Day 1), Day 3 up to Day 6
Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose Needed to Maintain Euglycemia
| Group | Value |
|---|---|
| 100 mg LY2409021 | not posted |
| 300 mg LY2409021 | not posted |
| Placebo | not posted |
Secondary outcomeGeometric mean· Day 3
Pharmacodynamics: Maximum Concentration (Cmax) of Glucose Concentration After 1 Milligram (mg) Glucagon Injection on Day 3
| Group | Value (milligrams per deciliter) | Spread |
|---|---|---|
| 100 mg LY2409021 | 154.9 | 19 |
| 300 mg LY2409021 | 141.3 | 19 |
| Placebo | 201.8 | 11 |
Secondary outcomeGeometric mean· Day 3
Pharmacodynamics: Area Under the Glucose Concentration Curve After a Single Dose of Glucagon on Day 3
| Group | Value (milligrams * minutes per deciliter) | Spread |
|---|---|---|
| 100 mg LY2409021 | 15534.3 | 21 |
| 300 mg LY2409021 | 14885.5 | 16 |
| Placebo | 20189.7 | 9 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| 100 mg LY2409021LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2. Placebo: 2 capsules, administered as a single oral dose on Day 2. Glucagon: 1 mg administered via intramuscular injection on Day 3. | – | 0 / 8 | 6 / 8 |
| 300 mg LY2409021LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2. Glucagon: 1 mg administered via intramuscular injection on Day 3. | – | 0 / 8 | 6 / 8 |
| PlaceboPlacebo: 3 capsules administered as a single oral dose on Day 2. Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3. | – | 0 / 4 | 4 / 4 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 65 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Have had type 1 diabetes mellitus (T1DM) based on the World Health Organization classification for at least 1 year and have a daily insulin dose ≤1.5 international units (IU) per kilogram (kg) of body weight
* Have a glycated hemoglobin A1c (HbA1c) of no greater than 9.0% as measured at screening
* Have a body mass index (BMI) ≥19.0 and ≤35.0 kilograms per meter squared (kg/m\^2)
* Have given written informed consent approved by Lilly
Exclusion Criteria:
* Received any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 3 months prior to screening
* Have had more than 1 episode of severe hypoglycemia within 3 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness
* Are pregnant or intend to become pregnant during the course of the study
* Women who are breastfeeding
* Have a history of stroke, myocardial infarction, heart failure, unstable angina, or a coronary revascularization procedure within 6 months of screening
* Have fasting triglycerides \>500 milligrams per deciliter (mg/dL) (5.65 millimoles per liter \[mmol/L\])
* Have obvious clinical signs, symptoms, or laboratory evidence of liver disease (alanine transaminase \[ALT\] or aspartate transaminase \[AST\] greater than 2 times the upper limit of normal at screening)
* Have a history of renal transplantation or are currently receiving renal dialysis or have a screening creatinine \>2.0 mg/dL (177 micromoles per liter \[μmol/L\])
* Have had any other disease, illness, or condition (including known diabetic autonomic neuropathy, drug or alcohol abuse, or psychiatric disorder) within the 6 months prior to screening that precludes the participant from following and completing the study or could increase their risk for hypoglycemia, according to the investigator's judgment
* Are currently enrolled in, have completed, or have discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
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