Trial · NCT01435616
A Study in Patients With Type 2 Diabetes Mellitus
NCT01435616, Phase 3, Completed, Eli Lilly and Company; results first posted 2018-04-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study in Patients With Type 2 Diabetes Mellitus. Trials, record NCT01435616. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01435616
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study in Patients With Type 2 Diabetes Mellitus
- NCT number
- NCT01435616
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,538 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Glargine, LY2605541
- First posted
- 2011-09-16
- Last updated
- 2018-04-13
- Results first posted
- 2018-04-13
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 to 52 Week Endpoint in Hemoglobin A1c (HbA1c) | Baseline, 52 weeks | HbA1C is a test that measures a person's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) with baseline HbA1c measurement, stratification factors (country, low density lipoprotein-cholesterol \[LDL-C, \< 100 milligrams per deciliter {mg/dL} and ≥ 100 mg/dL\] and sulfonylurea \[SU\]/meglitinide use), visit, treatment, and visit-by-treatment interaction as fixed effects. |
| Secondary | Rate of Total and Nocturnal Hypoglycemia Events | Baseline to 52 weeks | Hypoglycemia is a condition that occurs when a person's blood glucose level is lower than the normal range (less than or equal to 70 milligrams per deciliter \[mg/dL\] or less than 3.9 millimoles per liter \[mmol/L\]). Total hypoglycemia refers to an event that meets the criteria for documented symptomatic hypoglycemia, asymptomatic hypoglycemia, probable symptomatic hypoglycemia, unspecified hypoglycemia, or severe hypoglycemia. Nocturnal hypoglycemia refers to any total hypoglycemic event that occurs between bedtime and waking. Group mean (listed as LS means below) rates of total and nocturnal hypoglycemia were calculated using a negative binomial regression model (number of episodes = treatment + SU/meglitinide use + baseline hypoglycemia event rate, with log \[exposure per 30 days\] as the offset variable in the model). |
| Secondary | Percentage of Participants With Hemoglobin A1c Equal or Less Than 6.5% and Less Than 7.0 % | 52 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 | Fasting Serum Glucose (By Laboratory Measurement) | 52 weeks | LS means were calculated using a MMRM with baseline fasting serum glucose measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects. |
| Secondary | Fasting Blood Glucose (By Participant Self-monitored Blood Glucose Readings) | 52 weeks | LS means were calculated using a MMRM with baseline fasting blood glucose measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects. |
| Secondary | 6 Point Self-monitored Blood Glucose (SMBG) | 52 weeks | Six-point SMBG profiles were obtained at pre-morning meal (fasting), pre-midday meal (lunch), pre-evening meal (dinner), bedtime, approximately 0300 hours, and pre-morning meal (fasting) the next day. Six-point SMBG profiles were obtained over 2 nonconsecutive days within the week prior to the next office visit. LS means were calculated using a MMRM with baseline blood glucose measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects. |
| Secondary | Change From Baseline to 52 Weeks in Body Weight | Baseline, 52 weeks | LS means were calculated using a MMRM with baseline body weight measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects. |
| Secondary | Hemoglobin A1c | 52 weeks | HbA1c is a test that measures a person's average blood glucose level over the past 2 to 3 months. LS means were calculated using a MMRM with baseline HbA1C measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects. |
| Secondary | Insulin Dose Per Body Weight | 52 weeks | LS means were calculated using a MMRM with baseline insulin dose measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects. |
| Secondary | Number of Insulin Dose Adjustments to Steady-State | Baseline to 52 weeks | Insulin doses were adjusted according to an algorithm (adapted from Riddle et al. 2003) during the first 26 weeks of the study and thereafter according to investigator judgment. Steady-state was defined as the first local maximum dose (maximum of moving 4-week interval) of LY2605541 or glargine within the window of +/- 2 weeks. The number of dose adjustments to steady-state was the total number of dose changes until steady-state was reached. LS means were calculated using a MMRM with baseline insulin dose measurement, stratification factors (country, HbA1c, LDL-C \[\< 100 mg/dL and ≥ 100 mg/dL\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to 52 Week Endpoint in Hemoglobin A1c (HbA1c) | Baseline, 52 weeks | All participants who were randomized, had at least 1 dose of study medication, and at least 1 post-baseline HbA1c measurement. | percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Rate of Total and Nocturnal Hypoglycemia Events | Baseline to 52 weeks | All participants who were randomized, who received at least 1 dose of study drug, and had evaluable total and/or nocturnal event data. | episodes/participant/30 days | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Hemoglobin A1c Equal or Less Than 6.5% and Less Than 7.0 % | 52 weeks | All participants who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline HbA1c measurement. | percentage of participants | NUMBER |
| SECONDARY | Fasting Serum Glucose (By Laboratory Measurement) | 52 weeks | All participants who were randomized, received at least 1 dose of study drug, and had evaluable fasting serum glucose data. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Fasting Blood Glucose (By Participant Self-monitored Blood Glucose Readings) | 52 weeks | All participants who were randomized, received at least 1 dose of study drug, and had evaluable fasting blood glucose data. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | 6 Point Self-monitored Blood Glucose (SMBG) | 52 weeks | All participants who were randomized, received at least 1 dose of study drug, and had evaluable SMBG data. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 52 Weeks in Body Weight | Baseline, 52 weeks | All participants who were randomized, who received at least 1 dose of study drug, and had evaluable body weight data. | kilograms (kg) | LEAST_SQUARES_MEAN |
| SECONDARY | Hemoglobin A1c | 52 weeks | All participants who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline HbA1c measurement. | percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Insulin Dose Per Body Weight | 52 weeks | All participants who were randomized, received at least 1 dose of study drug, and had evaluable insulin dose data. | units of insulin/kg body weight | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Insulin Dose Adjustments to Steady-State | Baseline to 52 weeks | All participants who were randomized, received at least 1 dose of study drug, and had evaluable post-baseline insulin data. | number of insulin dose adjustments | LEAST_SQUARES_MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to 52 Week Endpoint in Hemoglobin A1c (HbA1c) | LY2605541 | -1.55 | Standard Error 0.03 | percentage of HbA1c | |
| Change From Baseline to 52 Week Endpoint in Hemoglobin A1c (HbA1c) | Glargine | -1.25 | Standard Error 0.04 | percentage of HbA1c | |
| Rate of Total and Nocturnal Hypoglycemia Events | LY2605541 | Rate of total hypoglycemia events | 1.16 | Standard Error 0.06 | episodes/participant/30 days |
| Rate of Total and Nocturnal Hypoglycemia Events | Glargine | Rate of total hypoglycemia events | 1.21 | Standard Error 0.07 | episodes/participant/30 days |
| Rate of Total and Nocturnal Hypoglycemia Events | LY2605541 | Rate of nocturnal hypoglycemia events | 0.30 | Standard Error 0.02 | episodes/participant/30 days |
| Rate of Total and Nocturnal Hypoglycemia Events | Glargine | Rate of nocturnal hypoglycemia events | 0.40 | Standard Error 0.03 | episodes/participant/30 days |
| Percentage of Participants With Hemoglobin A1c Equal or Less Than 6.5% and Less Than 7.0 % | LY2605541 | HbA1c ≤ 6.5% | 36.1 | percentage of participants | |
| Percentage of Participants With Hemoglobin A1c Equal or Less Than 6.5% and Less Than 7.0 % | Glargine | HbA1c ≤ 6.5% | 23.9 | percentage of participants | |
| Percentage of Participants With Hemoglobin A1c Equal or Less Than 6.5% and Less Than 7.0 % | LY2605541 | HbA1c < 7.0% | 57.6 | percentage of participants | |
| Percentage of Participants With Hemoglobin A1c Equal or Less Than 6.5% and Less Than 7.0 % | Glargine | HbA1c < 7.0% | 42.8 | percentage of participants |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LY2605541 | 1,003 | |
| Overall Study | STARTED | Glargine | 535 | |
| Overall Study | Received at Least 1 Dose of Study Drug | LY2605541 | 1,003 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Glargine | 535 | |
| Overall Study | COMPLETED | LY2605541 | 832 | |
| Overall Study | COMPLETED | Glargine | 455 | |
| Overall Study | NOT COMPLETED | LY2605541 | 171 | |
| Overall Study | NOT COMPLETED | Glargine | 80 |
Source ClinicalTrials.gov
Adverse events370
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 | Diarrhoea | Gastrointestinal disorders | LY2605541 | 57 | 1,003 | 81 |
| other | Diarrhoea | Gastrointestinal disorders | Glargine | 38 | 535 | 52 |
| other | Nausea | Gastrointestinal disorders | LY2605541 | 37 | 1,003 | 51 |
| other | Nausea | Gastrointestinal disorders | Glargine | 18 | 535 | 30 |
| other | Vomiting | Gastrointestinal disorders | LY2605541 | 35 | 1,003 | 49 |
| other | Vomiting | Gastrointestinal disorders | Glargine | 16 | 535 | 21 |
| other | Fatigue | General disorders | LY2605541 | 35 | 1,003 | 38 |
| other | Fatigue | General disorders | Glargine | 14 | 535 | 15 |
| other | Bronchitis | Infections and infestations | LY2605541 | 52 | 1,003 | 60 |
| other | Bronchitis | Infections and infestations | Glargine | 24 | 535 | 26 |
1 to 10 of 370Source ClinicalTrials.gov
See all 370 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LY2605541 | ||
| Total, all-cause mortality | Glargine | ||
| Total, other adverse events | LY2605541 | 733 | 1,003 |
| Total, other adverse events | Glargine | 390 | 535 |
| Total, serious adverse events | LY2605541 | 105 | 1,003 |
| Total, serious adverse events | Glargine | 73 | 535 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| LY2605541 vs Glargine: serious adverse events |
Source 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.
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/NCT01435616
GET https://conductscience.org/api/trials/v1/NCT01435616/results?page=2