Diabetes Mellitus, Type 2Phase 1NCT01300260

Effect of LY2189265 on Insulin Secretion in Response to Intravenous Glucose

A Phase 1 study testing LY2189265, Insulin and Glucose in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to measure the effect of LY2189265 to increase insulin levels in response to glucose intake. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: LY2189265, Insulin and Glucose
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 1 siteGermany
Study dates: Feb 2011to Aug 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

All Participants
Women must be surgically sterile (hysterectomy or bilateral oophorectomy or tubal ligation) or postmenopausal as defined by age >45 years without use of oral contraceptive agents for greater than 1 year and have either:
spontaneous amenorrhea greater than 12 months, or
spontaneous amenorrhea 6 to 12 months with documented follicle stimulating hormone (FSH) >25 milli international units/milliliter (mIU/mL) and serum estradiol <73 picomoles/liter (pmol/L) (20 picograms/milliliter [pg/mL])
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Have given written informed consent approved by Lilly and the ethical review board governing the site

Show all 20Show fewer

Have serum creatinine <150 micromoles/liter (µmol/L) (<1.3 milligrams/deciliter [mg/dl] in women, <170 µmol/L [<1.5 mg/dL] in men)
Have normal hemoglobin result, as determined by the investigator
Healthy Participants
Overtly healthy men and women as determined by medical history, normal lab results and physical examination.
Body mass index (BMI) between 19 and 25 kilograms/meter squared (kg/m^2), inclusive.
Normal blood pressure and heart rate as determined by the investigator
Have a normal response to an oral glucose tolerance test (OGTT) (glucose <7.8 millimoles/liter [mmol/L] [<140 mg/dL] at 2 hours after 75 grams (g) oral glucose load)
Participants with type 2 diabetes mellitus (T2DM)
Participants will have a BMI between 22.0 and 40.0 kg/m^2
Have T2DM controlled with diet and exercise alone or metformin for at least 4 weeks prior to admission
Have a hemoglobin A1c (HbA1c) value at screening (or within 4 weeks prior to screening) of 6.0% to 9.5%
Diagnosed with T2DM within the past 10 years
Clinical laboratory test results within normal range or deemed clinically insignificant by the Investigator. Abnormalities of serum glucose, serum lipids, urinary glucose, and urinary protein consistent with T2DM are acceptable.
Participants who are taking stable-dose prescription medications (for example, antihypertensive agents, aspirin, lipid-lowering agents) for treatment of concurrent medical conditions are permitted to participate providing the medication is not associated with development of torsade de pointes. However, use of beta-blockers and thiazide diuretics are not permitted during this study.

Who cannot join

All Participants
Within 30 days of the initial dose of study drug, have received treatment with a drug that has not received regulatory approval for any indication
Known allergies to Glucagon-Like Peptide 1 (GLP-1) related compounds
Have previously completed or withdrawn from this study or any other study in the last year investigating glucagon-like peptides or incretin mimetics including exenatide (Byetta®)
Regular use of known drugs of abuse and/or positive findings on urinary drug screening, other than findings consistent with medication prescribed by the participant's physician(s)
History or presence of cardiovascular, respiratory, renal, endocrine (except T2DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs or of constituting a risk when taking the study medication or interfering with the interpretation of data

Show all 30Show fewer

Have a history or presence of gastrointestinal disorder
Poorly controlled hypertension (systolic greater than 160 millimeters of mercury [mmHg], diastolic greater than 95 mmHg) and/or evidence of labile blood pressure including symptomatic postural hypotension. Use of beta-blockers or thiazide diuretics is not permitted during the study
Have a clinically significant history of cardiac disease or presence of active cardiac disease within 1 year of the screening period
Evidence of hepatitis C and/or positive hepatitis C antibody
Evidence of hepatitis B and/or positive hepatitis B surface antigen
Evidence of human immunodeficiency virus (HIV) and/or positive for HIV antibodies
Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females) or are unwilling to follow alcohol restrictions (1 unit = 12 ounces [oz] or 360 milliliters[mL] of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits).
Smoke more than 10 cigarettes or equivalent in nicotine use or nicotine substitutes per day
Regular use of systemic corticosteroids by oral, intravenous, or intramuscular route, or potent, inhaled, or intranasal steroids known to have a high rate of systemic absorption
Have a history or presence of significant active neuropsychiatric disease
Blood donation of more than 500 mL in the last 3 months or any blood donation within the last month
Any other condition, which in the opinion of the investigator would preclude participation in the study
An abnormality in the 12-lead electrocardiogram (ECG) that in the opinion of the investigator increases the risk of participating in the study.
Any clinically significant abnormal hematology, clinical chemistry, or urinary result(s) as determined by the investigator
Evidence of significant active uncontrolled endocrine or autoimmune abnormalities (for example thyroid disease, or pernicious anemia) as judged by the screening physician
Healthy Participants
Intended use of over-the-counter or prescription medication 7 and 14 days, respectively, prior to dosing.
Participants with T2DM
Clinically significant peripheral vascular occlusive disease (PVOD).
Known severe exudative diabetic retinopathy
Known significant autonomic neuropathy as evidenced by urinary retention, diabetic diarrhea, or gastroparesis
Have experienced a ketoacidotic episode (pH less than 7.3) requiring hospitalization in the last 6 months
Outpatient use of insulin for control of diabetes within the past 2 years
Use of antidiabetic agents other than metformin in the 4 weeks prior to study entry or use of thiazolidinediones within 12 weeks of study entry

Trial locations and contacts

1 site in 1 country.

Germany1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Neuss, D-41460

Other trials in Germany

About this study

Official title: The Effect of LY2189265 on Insulin Secretion in Response to Intravenous Glucose Infusion

The purpose of this study is to measure the effect of LY2189265 to increase insulin levels in response to glucose intake.

Conditions: Diabetes Mellitus, Type 2
Being tested: LY2189265, Placebo, Insulin, Glucose, Glucagon
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY2189265Biological
Also called Dulaglutide
Administered subcutaneously
PlaceboDrug
Administered subcutaneously
InsulinDrug
Also called Lispro
Administered intravenously
GlucoseDrug
Also called Dextrose
Administered intravenously
GlucagonDrug
Also called Glucagon hydrochloride
Administered intravenously

Study groups in NCT01300260
Study group	Role	What they receive
LY2189265 then Placebo	Experimental	LY2189265 (Dulaglutide) then Placebo: A single 1.5 milligram (mg) subcutaneous (SC) injection of LY2189265 on Day 1 in Period 1, followed by a single SC injection of Placebo on Day 1 in Period 2. On Day 3 of each period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose bolus (0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus of 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered. There was a washout period of at least 28 days between Periods 1 and 2. Receives: Biological: LY2189265; Drug: Placebo; Drug: Insulin; Drug: Glucose; Drug: Glucagon
Placebo then LY2189265	Experimental	Placebo then LY2189265 (Dulaglutide): A single subcutaneous injection of Placebo on Day 1 in Period 1, followed by a single 1.5 milligrams (mg) subcutaneous injection of LY2189265 on Day 1 in Period 2. On Day 3 of each period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose bolus (0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus of 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered. There was a washout period of at least 28 days between Periods 1 and 2. Receives: Biological: LY2189265; Drug: Placebo; Drug: Insulin; Drug: Glucose; Drug: Glucagon

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Insulin Concentration (Cmax) - First Phase Response
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.
Measured: 0-10 minutes after dextrose bolus on Day 3 postdose
Area Under the Insulin Concentration-time Curve (AUC) - First Phase Response
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.
Measured: 0-10 minutes after dextrose bolus on Day 3 postdose
Maximum Insulin Concentration (Cmax) - Second Phase Response
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.
Measured: 10-180 minutes after dextrose bolus on Day 3 postdose
Insulin Area Under the Curve (AUC) - Second Phase Response
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.
Measured: 10-180 minutes after dextrose bolus on Day 3 post dose

Secondary outcomes (1)

Insulin Maximum Concentration (Cmax)
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.
Measured: After glucagon bolus on Day 3 postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2011Aug 2011

First posted21 Feb 2011 (estimated)
Study startFeb 2011
Primary completionAug 2011
Study completionAug 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01300260
Sponsor's protocol ID: 11371
Other IDs: H9X-MC-GBCI
Status last verified: Oct 2014
First submitted: 3 Feb 2011
Last updated: 7 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of LY2189265 on Insulin Secretion in Response to Intravenous Glucose Infusion
ClinicalTrials.gov ID: NCT01300260
Acronym / sponsor ID: 11371
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Feb 2011
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 21 Feb 2011 (estimated)
Results: Posted 7 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to measure the effect of LY2189265 to increase insulin levels in response to glucose intake.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
LY2189265 then Placebo	Experimental	Biological: LY2189265, Drug: Placebo, Drug: Insulin, Drug: Glucose, Drug: GlucagonLY2189265 (Dulaglutide) then Placebo: A single 1.5 milligram (mg) subcutaneous (SC) injection of LY2189265 on Day 1 in Period 1, followed by a single SC injection of Placebo on Day 1 in Period 2. On Day 3 of each period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose bolus (0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus of 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered. There was a washout period of at least 28 days between Periods 1 and 2.
Placebo then LY2189265	Experimental	Biological: LY2189265, Drug: Placebo, Drug: Insulin, Drug: Glucose, Drug: GlucagonPlacebo then LY2189265 (Dulaglutide): A single subcutaneous injection of Placebo on Day 1 in Period 1, followed by a single 1.5 milligrams (mg) subcutaneous injection of LY2189265 on Day 1 in Period 2. On Day 3 of each period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose bolus (0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus of 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered. There was a washout period of at least 28 days between Periods 1 and 2.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (20 listed)

All Participants
Women must be surgically sterile (hysterectomy or bilateral oophorectomy or tubal ligation) or postmenopausal as defined by age >45 years without use of oral contraceptive agents for greater than 1 year and have either:
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Have given written informed consent approved by Lilly and the ethical review board governing the site
Have serum creatinine <150 micromoles/liter (µmol/L) (<1.3 milligrams/deciliter [mg/dl] in women, <170 µmol/L [<1.5 mg/dL] in men)

Key exclusion criteria (30 listed)

All Participants
Within 30 days of the initial dose of study drug, have received treatment with a drug that has not received regulatory approval for any indication
Known allergies to Glucagon-Like Peptide 1 (GLP-1) related compounds
Have previously completed or withdrawn from this study or any other study in the last year investigating glucagon-like peptides or incretin mimetics including exenatide (Byetta®)
Regular use of known drugs of abuse and/or positive findings on urinary drug screening, other than findings consistent with medication prescribed by the participant's physician(s)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY2189265Also: DulaglutideAdministered subcutaneously	Biological	LY2189265 then Placebo, Placebo then LY2189265
PlaceboAdministered subcutaneously	Drug	LY2189265 then Placebo, Placebo then LY2189265
InsulinAlso: LisproAdministered intravenously	Drug	LY2189265 then Placebo, Placebo then LY2189265
GlucoseAlso: DextroseAdministered intravenously	Drug	LY2189265 then Placebo, Placebo then LY2189265
GlucagonAlso: Glucagon hydrochlorideAdministered intravenously	Drug	LY2189265 then Placebo, Placebo then LY2189265

Primary outcome

Maximum Insulin Concentration (Cmax) - First Phase Response
Time frame: 0-10 minutes after dextrose bolus on Day 3 postdose
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.
Area Under the Insulin Concentration-time Curve (AUC) - First Phase Response
Time frame: 0-10 minutes after dextrose bolus on Day 3 postdose
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.
Maximum Insulin Concentration (Cmax) - Second Phase Response
Time frame: 10-180 minutes after dextrose bolus on Day 3 postdose
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.
Insulin Area Under the Curve (AUC) - Second Phase Response
Time frame: 10-180 minutes after dextrose bolus on Day 3 post dose
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.

1 secondary outcome

Insulin Maximum Concentration (Cmax)
Time frame: After glucagon bolus on Day 3 postdose

Results and safety

Results posted to the registry on 7 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LY2189265 First, Then Placebo	15	14
Placebo First, Then LY2189265	17	16

Primary outcome: Maximum Insulin Concentration (Cmax) - First Phase Response

Time frame: 0-10 minutes after dextrose bolus on Day 3 postdose. Geometric mean (95% Confidence Interval). Unit: picomole per liter (pmol/L)

Measure	Healthy Participants: Placebo n = 10	Healthy Participants: LY2189265 n = 10	Participants With Type 2 Diabetes Mellitus (T2DM): Placebo n = 21	Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265 n = 20
Value	233 (154 to 352)	689 (455 to 1041)	74.3 (46.8 to 118)	401 (252 to 637)

Healthy Participants: Placebo vs Healthy Participants: LY2189265: Geometric least squares (LS) mean ratio: 2.96 (95% CI 2.41 to 3.64), p <0.001, Mixed Models Analysis
Participants With Type 2 Diabetes Mellitus (T2DM): Placebo vs Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265: Geometric least squares (LS) means ratio: 5.40 (95% CI 4.09 to 7.13), p <0.001, Mixed Models Analysis

Population analysed: 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.

Primary outcome: Area Under the Insulin Concentration-time Curve (AUC) - First Phase Response

Time frame: 0-10 minutes after dextrose bolus on Day 3 postdose. Geometric mean (95% Confidence Interval). Unit: picomole times hour per liter (pmol*h/L)

Measure	Healthy Participants: Placebo n = 10	Healthy Participants: LY2189265 n = 10	Participants With Type 2 Diabetes Mellitus (T2DM): Placebo n = 21	Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265 n = 20
Value	22.9 (15.0 to 34.9)	70.7 (46.3 to 108)	5.06 (2.90 to 8.83)	40.1 (22.8 to 70.3)

Healthy Participants: Placebo vs Healthy Participants: LY2189265: Geometric least squares (LS) mean ratio: 3.09 (95% CI 2.66 to 3.59), p <0.001, Mixed Models Analysis
Participants With Type 2 Diabetes Mellitus (T2DM): Placebo vs Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265: Geometric least squares (LS) mean ratio: 7.92 (95% CI 4.82 to 13.0), p <0.001, Mixed Models Analysis

Population analysed: 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.

Primary outcome: Maximum Insulin Concentration (Cmax) - Second Phase Response

Time frame: 10-180 minutes after dextrose bolus on Day 3 postdose. Geometric mean (95% Confidence Interval). Unit: picomole per liter (pmol/L)]

Measure	Healthy Participants: Placebo n = 8	Healthy Participants: LY2189265 n = 8	Participants With Type 2 Diabetes Mellitus (T2DM): Placebo n = 21	Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265 n = 20
Value	89.2 (64.7 to 123)	370 (269 to 511)	95.9 (66.3 to 139)	363 (250 to 526)

Healthy Participants: Placebo vs Healthy Participants: LY2189265: Geometric least squares (LS) mean ratio: 4.15 (95% CI 3.45 to 5.00), p <0.001, Mixed Models Analysis
Participants With Type 2 Diabetes Mellitus (T2DM): Placebo vs Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265: Geometric least squares (LS) mean ratio: 3.78 (95% CI 2.99 to 4.78), p <0.001, Mixed Models Analysis

Primary outcome: Insulin Area Under the Curve (AUC) - Second Phase Response

Time frame: 10-180 minutes after dextrose bolus on Day 3 post dose. Geometric mean (95% Confidence Interval). Unit: picomole times hour per liter (pmol*h/L)

Measure	Healthy Participants: Placebo n = 8	Healthy Participants: LY2189265 n = 8	Participants With Type 2 Diabetes Mellitus (T2DM): Placebo n = 21	Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265 n = 20
Value	68.8 (41.7 to 114)	141 (85.3 to 232)	147 (103 to 209)	357 (250 to 511)

Healthy Participants: Placebo vs Healthy Participants: LY2189265: Geometric least squares (LS) mean ratio: 2.04 (95% CI 1.26 to 3.31), p = 0.011, Mixed Models Analysis
Participants With Type 2 Diabetes Mellitus (T2DM): Placebo vs Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265: Geometric least squares (LS) mean ratio: 2.44 (95% CI 1.71 to 3.47), p <0.001, Mixed Models Analysis

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Participants: Placebo	0 of 10 (0%)	2 of 10 (20%)	Not reported
Healthy Participants: LY2189265	0 of 10 (0%)	6 of 10 (60%)	Not reported
Participants With Type 2 Diabetes Mellitus (T2DM): Placebo	0 of 21 (0%)	9 of 21 (42.9%)	Not reported
Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265	0 of 21 (0%)	11 of 21 (52.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2189265, Insulin and Glucose in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Insulin Concentration (Cmax) - First Phase Response (time frame: 0-10 minutes after dextrose bolus on Day 3 postdose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01300260.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2014.