Trial Outcomes & Findings for Effect of LY2189265 on Insulin Secretion in Response to Intravenous Glucose (NCT NCT01300260)

Last Updated: 2014-10-07

Results Overview

On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \[T2DM\]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Maximum plasma insulin concentration from 0 to 10 minutes (INSCmax\[0-10\]) following the first dextrose bolus (the first phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

32 participants

Primary outcome timeframe

0-10 minutes after dextrose bolus on Day 3 postdose

Results posted on

2014-10-07

Participant Flow

Participant milestones

Participant milestones
Measure	LY2189265 First, Then Placebo Includes healthy participants or participants with T2DM. LY2189265 (Dulaglutide): Single 1.5 milligram (mg) subcutaneous (SC) injection on Day 1 of Period 1. Placebo: Single SC injection of Placebo on Day 1 of Period 2. On Day 3 of each period, participants received a 6-hour (hr) insulin infusion, followed by an intravenous (IV) dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes \[min\]). Three hr later, a 2nd IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hr glucose between 5.2 and 10 millimole/liter \[mmol/L\] or 15 g of 50% dextrose for participants with 3-hr glucose \>10 mmol/L) was administered, followed by a 20% dextrose at the set infusion rate of 600 milliliter/hr \[mL/hr\] for 35 min. Fifteen min after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered. There was a washout period of ≥28 days between Periods 1 \& 2.	Placebo First, Then LY2189265 Includes healthy participants and participants with T2DM. Placebo: Single subcutaneous (SC) injection of Placebo on Day 1 of Period 1. LY2189265 (Dulaglutide): Single 1.5 milligram (mg) SC injection on Day 1 of Period 2. On Day 3 of each period, participants received a 6-hour (hr) insulin infusion, followed by an intravenous (IV) dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes \[min\]). Three hr later, a 2nd IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hr glucose between 5.2 and 10 millimole/liter \[mmol/L\] or 15 g of 50% dextrose for participants with 3-hr glucose \>10 mmol/L) was administered, followed by a 20% dextrose at the set infusion rate of 600 milliliter/hr \[mL/hr\] for 35 min. Fifteen min after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered. There was a washout period of ≥28 days between Periods 1 \& 2.
Period 1 of Study: First Intervention STARTED	15	17
Period 1 of Study: First Intervention Received at Least 1 Dose of Study Drug	15	17
Period 1 of Study: First Intervention COMPLETED	14	16
Period 1 of Study: First Intervention NOT COMPLETED	1	1
Washout Period of at Least 28 Days STARTED	14	16
Washout Period of at Least 28 Days COMPLETED	14	16
Washout Period of at Least 28 Days NOT COMPLETED	0	0
Period 2 of Study: Second Intervention STARTED	14	16
Period 2 of Study: Second Intervention COMPLETED	14	15
Period 2 of Study: Second Intervention NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	LY2189265 First, Then Placebo Includes healthy participants or participants with T2DM. LY2189265 (Dulaglutide): Single 1.5 milligram (mg) subcutaneous (SC) injection on Day 1 of Period 1. Placebo: Single SC injection of Placebo on Day 1 of Period 2. On Day 3 of each period, participants received a 6-hour (hr) insulin infusion, followed by an intravenous (IV) dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes \[min\]). Three hr later, a 2nd IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hr glucose between 5.2 and 10 millimole/liter \[mmol/L\] or 15 g of 50% dextrose for participants with 3-hr glucose \>10 mmol/L) was administered, followed by a 20% dextrose at the set infusion rate of 600 milliliter/hr \[mL/hr\] for 35 min. Fifteen min after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered. There was a washout period of ≥28 days between Periods 1 \& 2.	Placebo First, Then LY2189265 Includes healthy participants and participants with T2DM. Placebo: Single subcutaneous (SC) injection of Placebo on Day 1 of Period 1. LY2189265 (Dulaglutide): Single 1.5 milligram (mg) SC injection on Day 1 of Period 2. On Day 3 of each period, participants received a 6-hour (hr) insulin infusion, followed by an intravenous (IV) dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes \[min\]). Three hr later, a 2nd IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hr glucose between 5.2 and 10 millimole/liter \[mmol/L\] or 15 g of 50% dextrose for participants with 3-hr glucose \>10 mmol/L) was administered, followed by a 20% dextrose at the set infusion rate of 600 milliliter/hr \[mL/hr\] for 35 min. Fifteen min after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered. There was a washout period of ≥28 days between Periods 1 \& 2.
Period 1 of Study: First Intervention Adverse Event	0	1
Period 1 of Study: First Intervention Withdrawal by Subject	1	0
Period 2 of Study: Second Intervention Adverse Event	0	1

Baseline Characteristics

Effect of LY2189265 on Insulin Secretion in Response to Intravenous Glucose

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Participants n=10 Participants Includes healthy participants randomized to receive 1.5 milligram (mg) LY2189265 (Dulaglutide) first or Placebo first on Day 1 of either treatment sequence.	Participants With Type 2 Diabetes Mellitus (T2DM) n=22 Participants Includes participants with T2DM randomized to receive 1.5 mg LY2189265 (Dulaglutide) first or Placebo first on Day 1 of either treatment sequence.	Total n=32 Participants Total of all reporting groups
Age, Continuous	51.9 years STANDARD_DEVIATION 5.0 • n=5 Participants	56.3 years STANDARD_DEVIATION 6.1 • n=7 Participants	54.9 years STANDARD_DEVIATION 6.1 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	15 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	22 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	22 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Germany	10 participants n=5 Participants	22 participants n=7 Participants	32 participants n=5 Participants

PRIMARY outcome

Timeframe: 0-10 minutes after dextrose bolus on Day 3 postdose

Population: All participants (healthy and with type 2 diabetes mellitus \[T2DM\]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSCmax(0-10) first response phase data.

Outcome measures

Outcome measures
Measure	Healthy Participants: Placebo n=10 Participants Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes).	Healthy Participants: LY2189265 n=10 Participants Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes).	Participants With Type 2 Diabetes Mellitus (T2DM): Placebo n=21 Participants T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes).	Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265 n=20 Participants T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes).
Maximum Insulin Concentration (Cmax) - First Phase Response	233 picomole per liter (pmol/L) Interval 154.0 to 352.0	689 picomole per liter (pmol/L) Interval 455.0 to 1041.0	74.3 picomole per liter (pmol/L) Interval 46.8 to 118.0	401 picomole per liter (pmol/L) Interval 252.0 to 637.0

PRIMARY outcome

Timeframe: 0-10 minutes after dextrose bolus on Day 3 postdose

Population: All participants (healthy and with type 2 diabetes mellitus \[T2DM\]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSAUC(0-10) first phase response data.

On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \[T2DM\]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Area under the plasma insulin concentration time curve from 0 to 10 minutes (INSAUC\[0-10\]) following the first dextrose bolus (the first phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.

Outcome measures

Outcome measures
Measure	Healthy Participants: Placebo n=10 Participants Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes).	Healthy Participants: LY2189265 n=10 Participants Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes).	Participants With Type 2 Diabetes Mellitus (T2DM): Placebo n=21 Participants T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes).	Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265 n=20 Participants T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes).
Area Under the Insulin Concentration-time Curve (AUC) - First Phase Response	22.9 picomole times hour per liter (pmol*h/L) Interval 15.0 to 34.9	70.7 picomole times hour per liter (pmol*h/L) Interval 46.3 to 108.0	5.06 picomole times hour per liter (pmol*h/L) Interval 2.9 to 8.83	40.1 picomole times hour per liter (pmol*h/L) Interval 22.8 to 70.3

PRIMARY outcome

Timeframe: 10-180 minutes after dextrose bolus on Day 3 postdose

Population: All participants (healthy and with type 2 diabetes mellitus \[T2DM\]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSCmax(10-180) second response phase data.

On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \[T2DM\]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Maximum plasma insulin concentration from 10 to 180 minutes (INSCmax\[10-180\]) following the first dextrose bolus (the second phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.

Outcome measures

Outcome measures
Measure	Healthy Participants: Placebo n=8 Participants Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes).	Healthy Participants: LY2189265 n=8 Participants Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes).	Participants With Type 2 Diabetes Mellitus (T2DM): Placebo n=21 Participants T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes).	Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265 n=20 Participants T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes).
Maximum Insulin Concentration (Cmax) - Second Phase Response	89.2 picomole per liter (pmol/L)] Interval 64.7 to 123.0	370 picomole per liter (pmol/L)] Interval 269.0 to 511.0	95.9 picomole per liter (pmol/L)] Interval 66.3 to 139.0	363 picomole per liter (pmol/L)] Interval 250.0 to 526.0

PRIMARY outcome

Timeframe: 10-180 minutes after dextrose bolus on Day 3 post dose

Population: All participants (healthy and with type 2 diabetes mellitus \[T2DM\]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSAUC(10-180) second response phase data.

On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \[T2DM\]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Area under the plasma insulin concentration time curve from 10 to 180 minutes (INSAUC\[10-180\]) following the first dextrose bolus (the second phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.

Outcome measures

Outcome measures
Measure	Healthy Participants: Placebo n=8 Participants Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes).	Healthy Participants: LY2189265 n=8 Participants Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes).	Participants With Type 2 Diabetes Mellitus (T2DM): Placebo n=21 Participants T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes).	Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265 n=20 Participants T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes).
Insulin Area Under the Curve (AUC) - Second Phase Response	68.8 picomole times hour per liter (pmol*h/L) Interval 41.7 to 114.0	141 picomole times hour per liter (pmol*h/L) Interval 85.3 to 232.0	147 picomole times hour per liter (pmol*h/L) Interval 103.0 to 209.0	357 picomole times hour per liter (pmol*h/L) Interval 250.0 to 511.0

SECONDARY outcome

Timeframe: After glucagon bolus on Day 3 postdose

Population: All participants (healthy or with type 2 diabetes mellitus \[T2DM\]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSCmaxG data.

On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \[T2DM\]) received a single subcutaneous dose of either LY2189265 or placebo. Maximum plasma insulin concentration from -2 to 20 minutes following the glucagon bolus (INSCmaxG) is presented.

Outcome measures

Outcome measures
Measure	Healthy Participants: Placebo n=8 Participants Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes).	Healthy Participants: LY2189265 n=8 Participants Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes).	Participants With Type 2 Diabetes Mellitus (T2DM): Placebo n=20 Participants T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes).	Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265 n=20 Participants T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes).
Insulin Maximum Concentration (Cmax)	996 picomole per liter (pmol/L) Interval 716.0 to 1386.0	1215 picomole per liter (pmol/L) Interval 874.0 to 1690.0	1088 picomole per liter (pmol/L) Interval 827.0 to 1431.0	1514 picomole per liter (pmol/L) Interval 1151.0 to 1991.0

OTHER_PRE_SPECIFIED outcome

Timeframe: After glucagon bolus on Day 3 postdose

Population: All participants (healthy or with type 2 diabetes mellitus \[T2DM\]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSAUCG data.

On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \[T2DM\]) received a single subcutaneous dose of either LY2189265 or placebo. Area under the plasma insulin concentration-time curve from -2 to 20 minutes following the glucagon bolus (INSAUCG) is presented.

Outcome measures

Outcome measures
Measure	Healthy Participants: Placebo n=8 Participants Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes).	Healthy Participants: LY2189265 n=8 Participants Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes).	Participants With Type 2 Diabetes Mellitus (T2DM): Placebo n=20 Participants T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes).	Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265 n=20 Participants T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \[g/kg\] over approximately 2 minutes).
Area Under the Insulin Concentration-time Curve (AUC)	239 picomole times hour per liter (pmol*h/L) Interval 167.0 to 340.0	341 picomole times hour per liter (pmol*h/L) Interval 239.0 to 486.0	236 picomole times hour per liter (pmol*h/L) Interval 177.0 to 316.0	414 picomole times hour per liter (pmol*h/L) Interval 310.0 to 554.0

Adverse Events

Healthy Participants: Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Healthy Participants: LY2189265

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Participants With Type 2 Diabetes Mellitus (T2DM): Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Healthy Participants: Placebo n=10 participants at risk Healthy participants who received at least 1 subcutaneous injection of Placebo	Healthy Participants: LY2189265 n=10 participants at risk Healthy participants who received at least 1 subcutaneous injection of 1.5 milligram (mg) LY2189265	Participants With Type 2 Diabetes Mellitus (T2DM): Placebo n=21 participants at risk T2DM participants who received at least 1 subcutaneous injection of Placebo	Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265 n=21 participants at risk T2DM participants who received at least 1 subcutaneous injection of 1.5 milligram (mg) LY2189265
Gastrointestinal disorders Abdominal distension	0.00% 0/10	10.0% 1/10 • Number of events 1	4.8% 1/21 • Number of events 1	0.00% 0/21
Gastrointestinal disorders Dyspepsia	0.00% 0/10	10.0% 1/10 • Number of events 1	0.00% 0/21	0.00% 0/21
Gastrointestinal disorders Nausea	10.0% 1/10 • Number of events 1	0.00% 0/10	4.8% 1/21 • Number of events 1	9.5% 2/21 • Number of events 3
Gastrointestinal disorders Vomiting	10.0% 1/10 • Number of events 1	10.0% 1/10 • Number of events 1	0.00% 0/21	19.0% 4/21 • Number of events 4
General disorders Infusion site phlebitis	10.0% 1/10 • Number of events 1	0.00% 0/10	0.00% 0/21	0.00% 0/21
General disorders Injection site oedema	0.00% 0/10	10.0% 1/10 • Number of events 1	4.8% 1/21 • Number of events 1	0.00% 0/21
General disorders Injection site phlebitis	10.0% 1/10 • Number of events 1	0.00% 0/10	9.5% 2/21 • Number of events 2	4.8% 1/21 • Number of events 1
General disorders Injection site thrombosis	0.00% 0/10	10.0% 1/10 • Number of events 1	4.8% 1/21 • Number of events 1	0.00% 0/21
General disorders Malaise	0.00% 0/10	10.0% 1/10 • Number of events 1	0.00% 0/21	4.8% 1/21 • Number of events 1
General disorders Vessel puncture site pain	10.0% 1/10 • Number of events 1	0.00% 0/10	0.00% 0/21	0.00% 0/21
Metabolism and nutrition disorders Decreased appetite	0.00% 0/10	0.00% 0/10	4.8% 1/21 • Number of events 1	9.5% 2/21 • Number of events 2
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/10	40.0% 4/10 • Number of events 5	0.00% 0/21	0.00% 0/21
Nervous system disorders Dizziness	0.00% 0/10	10.0% 1/10 • Number of events 2	4.8% 1/21 • Number of events 2	0.00% 0/21
Nervous system disorders Headache	0.00% 0/10	0.00% 0/10	14.3% 3/21 • Number of events 3	9.5% 2/21 • Number of events 2
Psychiatric disorders Disorientation	0.00% 0/10	10.0% 1/10 • Number of events 1	0.00% 0/21	0.00% 0/21
Vascular disorders Pallor	0.00% 0/10	10.0% 1/10 • Number of events 1	0.00% 0/21	0.00% 0/21

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60