Trial · NCT01468987

A Study in Participants With Type 2 Diabetes Mellitus

NCT01468987, Phase 3, Completed, Eli Lilly and Company; results first posted 2018-04-17

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study in Participants With Type 2 Diabetes Mellitus. Trials, record NCT01468987. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01468987

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study in Participants With Type 2 Diabetes Mellitus
NCT number: NCT01468987
Status: Completed
Phases: Phase 3
Enrollment: 1,369 participants, actual
Lead sponsor: Eli Lilly and Company
Conditions: Diabetes Mellitus, Type 2
Interventions: LY2605541, Insulin Glargine, Insulin Lispro
First posted: 2011-11-10
Last updated: 2018-04-17
Other registries' IDs: eudract:2011-001254-29
Results first posted: 2018-04-17

Source ClinicalTrials.gov

Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks	Baseline, 26 weeks	HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for stratification factors (country, low-density lipoprotein cholesterol \[LDL-C, \<100 milligrams per deciliter (mg/dL) and ≥100 mg/dL\], and number of insulin injections at baseline \[1, 2, or ≥3\]), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.
Secondary	Total Hypoglycemia Rates (Adjusted for 30 Days)	Baseline through 26 weeks	Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 millimoles per liter \[mmol/L\]). Group mean rates of total hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline total hypoglycemia rate, with log \[exposure in days/30\] as an offset variable). Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.
Secondary	Percentage of Participants With Total Hypoglycemia Episodes	Baseline through 26 weeks	Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 mg/dL (3.9 mmol/L). The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, multiplied by 100.
Secondary	Nocturnal Hypoglycemia Rates (Adjusted for 30 Days)	Baseline through 26 weeks	Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or a documented BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. Group mean rates of nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline nocturnal hypoglycemia rate, with log \[exposure in days/30\] as an offset variable). Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.
Secondary	Percentage of Participants With Nocturnal Hypoglycemia Episodes	Baseline through 26 weeks	Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia and/or a BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with nocturnal hypoglycemic episodes by the total number of participants analyzed, multiplied by 100.
Secondary	Body Weight Change From Baseline to 26 Weeks	Baseline, 26 weeks	LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c \[≤8.5% and \>8.5%\], country, LDL-C \[\<100 mg/dL and ≥100 mg/dL\], and number of insulin injections at baseline \[1, 2, or ≥3\]), treatment, visit, treatment-by-visit interaction, and baseline body weight as fixed effects, and participant as a random effect.
Secondary	Self-Monitored Blood Glucose (SMBG) 9-point Profiles at 26 Weeks	26 weeks	9-point SMBG profiles were obtained over 2 nonconsecutive days within the week prior to Weeks 0, 4, 12, and 26. SMBG measurements were taken at 9 time points: pre-morning meal, 2 hours post-morning meal, pre-midday meal, 2 hours post-midday meal, pre-evening meal, 2 hours post-evening meal, bedtime, at approximately 0300 hours, and the subsequent morning prior to the morning meal. LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c \[≤8.5% and \>8.5%\], country, LDL-C \[\<100 mg/dL and ≥100 mg/dL\], and number of insulin injections at baseline \[1, 2, or ≥3\]), visit, treatment, visit-by-treatment interaction, and baseline BG values.
Secondary	Percentage of Participants With HbA1c <7.0% and ≤6.5% at 26 Weeks	up to 26 weeks	The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.
Secondary	Percentage of Participants With HbA1c <7.0% Without Nocturnal Hypoglycemia at 26 Weeks	up to 26 weeks	Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with HbA1c \<7.0% without nocturnal hypoglycemia by the total number of participants analyzed, multiplied by 100.
Secondary	Basal, Bolus, and Total Insulin Dose by Weight at 26 Weeks	26 weeks	Basal insulin dose, short-acting bolus insulin dose (each meal and overall), and total insulin dose were calculated based on the dose during the last 7 days prior to the post-treatment visit or last 3 days prior to the randomization visit. LS means were calculated using a constrained Longitudinal Data Analysis (cLDA) model adjusting for indicator variables of each treatment group at each post-baseline visit and stratification variables (baseline HbA1c \[≤8.5% and \>8.5%\], country, baseline LDL-C \[\<100 mg/dL and ≥100 mg/dL\], and baseline number of insulin injections \[1, 2, or ≥3\]).

1 to 10 of 20Source ClinicalTrials.gov

See all 20 registered outcomes

Outcomes20

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks	Baseline, 26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.	percentage of HbA1c	LEAST_SQUARES_MEAN
SECONDARY	Total Hypoglycemia Rates (Adjusted for 30 Days)	Baseline through 26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.	episodes/participant/30 days	MEAN
SECONDARY	Percentage of Participants With Total Hypoglycemia Episodes	Baseline through 26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.	percentage of participants	NUMBER
SECONDARY	Nocturnal Hypoglycemia Rates (Adjusted for 30 Days)	Baseline through 26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.	events/participant/30 days	MEAN
SECONDARY	Percentage of Participants With Nocturnal Hypoglycemia Episodes	Baseline through 26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.	percentage of participants	NUMBER
SECONDARY	Body Weight Change From Baseline to 26 Weeks	Baseline, 26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable body weight data at both baseline and post-baseline.	kilograms (kg)	LEAST_SQUARES_MEAN
SECONDARY	Self-Monitored Blood Glucose (SMBG) 9-point Profiles at 26 Weeks	26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable SMBG data at both baseline and post-baseline.	mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With HbA1c <7.0% and ≤6.5% at 26 Weeks	up to 26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With HbA1c <7.0% Without Nocturnal Hypoglycemia at 26 Weeks	up to 26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data. Missing endpoints were imputed with the LOCF method, using only post-baseline data.	percentage of participants	NUMBER
SECONDARY	Basal, Bolus, and Total Insulin Dose by Weight at 26 Weeks	26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable insulin dose data.	units/kg/day	LEAST_SQUARES_MEAN

1 to 10 of 20Source ClinicalTrials.gov

See all 20 outcomes

Results by group82

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks	LY2605541 + Insulin Lispro	-1.66	Standard Error 0.04	percentage of HbA1c
Change From Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks	Insulin Glargine + Insulin Lispro	-1.45	Standard Error 0.04	percentage of HbA1c
Total Hypoglycemia Rates (Adjusted for 30 Days)	LY2605541 + Insulin Lispro	5.97	Standard Error 0.20	episodes/participant/30 days
Total Hypoglycemia Rates (Adjusted for 30 Days)	Insulin Glargine + Insulin Lispro	5.42	Standard Error 0.19	episodes/participant/30 days
Percentage of Participants With Total Hypoglycemia Episodes	LY2605541 + Insulin Lispro	95.2		percentage of participants
Percentage of Participants With Total Hypoglycemia Episodes	Insulin Glargine + Insulin Lispro	96.6		percentage of participants
Nocturnal Hypoglycemia Rates (Adjusted for 30 Days)	LY2605541 + Insulin Lispro	0.51	Standard Error 0.03	events/participant/30 days
Nocturnal Hypoglycemia Rates (Adjusted for 30 Days)	Insulin Glargine + Insulin Lispro	0.92	Standard Error 0.05	events/participant/30 days
Percentage of Participants With Nocturnal Hypoglycemia Episodes	LY2605541 + Insulin Lispro	59.5		percentage of participants
Percentage of Participants With Nocturnal Hypoglycemia Episodes	Insulin Glargine + Insulin Lispro	74.0		percentage of participants

1 to 10 of 82Source ClinicalTrials.gov

See all 82 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	LY2605541 + Insulin Lispro	691
Overall Study	STARTED	Insulin Glargine + Insulin Lispro	678
Overall Study	Received at Least 1 Dose of Study Drug	LY2605541 + Insulin Lispro	691
Overall Study	Received at Least 1 Dose of Study Drug	Insulin Glargine + Insulin Lispro	677
Overall Study	COMPLETED	LY2605541 + Insulin Lispro	620
Overall Study	COMPLETED	Insulin Glargine + Insulin Lispro	618
Overall Study	NOT COMPLETED	LY2605541 + Insulin Lispro	71
Overall Study	NOT COMPLETED	Insulin Glargine + Insulin Lispro	60

Source ClinicalTrials.gov

Adverse events336

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diabetic retinopathy	Eye disorders	LY2605541 + Insulin Lispro	7	691	8
other	Diabetic retinopathy	Eye disorders	Insulin Glargine + Insulin Lispro	5	677	5
other	Abdominal pain	Gastrointestinal disorders	LY2605541 + Insulin Lispro	7	691	7
other	Abdominal pain	Gastrointestinal disorders	Insulin Glargine + Insulin Lispro	4	677	4
other	Constipation	Gastrointestinal disorders	LY2605541 + Insulin Lispro	9	691	9
other	Constipation	Gastrointestinal disorders	Insulin Glargine + Insulin Lispro	6	677	6
other	Diarrhoea	Gastrointestinal disorders	LY2605541 + Insulin Lispro	24	691	27
other	Diarrhoea	Gastrointestinal disorders	Insulin Glargine + Insulin Lispro	19	677	22
other	Gastrooesophageal reflux disease	Gastrointestinal disorders	LY2605541 + Insulin Lispro	7	691	7
other	Gastrooesophageal reflux disease	Gastrointestinal disorders	Insulin Glargine + Insulin Lispro	4	677	4

1 to 10 of 336Source ClinicalTrials.gov

See all 336 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	LY2605541 + Insulin Lispro
Total, all-cause mortality	Insulin Glargine + Insulin Lispro
Total, other adverse events	LY2605541 + Insulin Lispro	408	691
Total, other adverse events	Insulin Glargine + Insulin Lispro	406	677
Total, serious adverse events	LY2605541 + Insulin Lispro	79	691
Total, serious adverse events	Insulin Glargine + Insulin Lispro	63	677

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36542287	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
LY2605541 + Insulin Lispro vs Insulin Glargine + Insulin Lispro: Number of Participants With Change in Anti-LY2605541 Antibodies From Baseline to 26 Weeks	Trial comparisons
LY2605541 + Insulin Lispro vs Insulin Glargine + Insulin Lispro: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01468987

GET https://conductscience.org/api/trials/v1/NCT01468987/results?page=2

API reference For AI assistants