Phase 3
Completed N=641
A Study to Compare a New Long-Acting Insulin (LY2605541) and Human Insulin NPH in Participants With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01790438 ↗Enrolled (actual)
641
Serious AEs
5.8%
Results posted
May 2018
Primary outcomePrimary: Change From Baseline to 26 Weeks in Hemoglobin A1c (HbA1c) — -1.73; -1.36 percentage of HbA1c
◆ Published Evidence
Emerging
5citations · ~2 / year
Accurate Collection of Reasons for Treatment Discontinuation to Better Define Estimands in Clinical Trials.
Summary
The purpose of this study is to compare LY2605541 and human insulin isophane suspension (NPH) using the following measures for participants treated for up to 26 weeks:
* Change in participants' overall blood sugar control
* The rate of night time low blood sugar episodes
* The number of participants that reach blood sugar targets without low night time blood sugar episodes
* The total number of low blood sugar episodes reported
Linked Publications
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Accurate Collection of Reasons for Treatment Discontinuation to Better Define Estimands in Clinical Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 26 Weeks in Hemoglobin A1c (HbA1c) |
-1.73; -1.36 | — |
| SECONDARY 30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events |
1.46; 1.73; 0.31; 0.61 | — |
| SECONDARY Percentage of Participants With HbA1c ≤6.5% and <7.0% |
43.4; 24.1; 66.3; 44.7 | — |
| SECONDARY Fasting Serum Glucose (FSG) (by Laboratory) |
112.61; 118.60 | — |
| SECONDARY Fasting Blood Glucose (FBG) (by Self Monitoring) |
111.37; 109.75 | — |
| SECONDARY 6-Point Self-Monitored Blood Glucose (SMBG) |
111.22; 109.56; 123.78; 133.77; 130.90; 146.99 | — |
| SECONDARY Change From Baseline to 26 Weeks in Body Weight |
2.02; 2.34 | — |
| SECONDARY HbA1c |
6.76; 7.12 | — |
| SECONDARY Insulin Dose Per Kilogram (kg) of Body Weight |
0.40; 0.35 | — |
| SECONDARY Time to Steady-State (Stable Maximum Dose) |
7.14; 5.86 | — |
| SECONDARY Change From Baseline to 26 Weeks in European Quality of Life - 5 Dimension 3 Levels (EQ-5D-3L) Index |
0.02; 0.01 | — |
| SECONDARY Insulin Treatment Satisfaction Questionnaire (ITSQ) Score |
85.04; 83.84 | — |
| SECONDARY Change From Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores |
0.53; 2.05 | — |
| SECONDARY Change From Baseline to 26 Weeks in Lipid Profile |
2.08; 2.86; -0.12; 2.94; -0.24; 0.41 | — |
| SECONDARY Percentage of Participants With Insulin Antibodies |
19.7; 45.8 | — |
| SECONDARY Intra-Participant Variability in FBG by Standard Deviation |
14.44; 19.07 | — |
| SECONDARY Intra-Participant Variability in FBG by the Coefficient of Variation |
12.87; 17.05 | — |
| SECONDARY Percentage of Participants With Total and Nocturnal Hypoglycemic Events |
76.7; 83.5; 41.6; 67.5 | — |
| SECONDARY Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia |
39.1; 12.6 | — |
| SECONDARY Percentage of Participants With Injection Site Reactions |
0.9; 1.4 | — |
| SECONDARY Rate of Severe Hypoglycemic Events |
1.00; 0.00 | — |
| SECONDARY Percentage of Participants With Severe Hypoglycemic Events |
0.5; 0.0 | — |
| SECONDARY Change From Baseline to 26 Weeks in European Quality of Life (EQ-5D-3L) - Visual Analog Scales (VAS) Scores |
2.52; 1.41 | — |
Eligibility Criteria
Inclusion Criteria
- Have had type 2 diabetes mellitus for at least 1 year, not treated with insulin
- Have been receiving 2 or more OAMs for at least 3 months prior to the study
- Have a hemoglobin A1c (HbA1c) of 7.0% to 11.0%, inclusive, at screening
- Have a body mass index (BMI) less than or equal to 45.0 kilograms per square meter (kg/m^2)
- Women of childbearing potential are not breastfeeding, have a negative pregnancy test at screening and randomization, do not plan to become pregnant during the study, have practiced reliable birth control for at least 6 weeks prior to screening and will continue to do so during the study and until 2 weeks after the last dose of study drug
Exclusion Criteria
- Have used insulin therapy in the past 2 years (except for use during pregnancy or for short term use for acute conditions)
- Have been treated with glucagon-like peptide-1 (GLP-1) receptor agonist, rosiglitazone, pramlintide, or weight-loss medication within 3 months before screening
- For participants on OAMs: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations
- Are taking, or have taken within the 90 days before screening, prescription or over-the-counter medications to promote weight loss
- Have had any episodes of severe hypoglycemia, diabetic ketoacidosis, or hyperosmolar state/coma within 6 months prior to screening
- Have cardiac disease with functional status that is New York Heart Association Class III or IV
- Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater than or equal to 2 milligrams per deciliter (mg/dL) [177 millimoles per liter (mmol/L)]
- Have obvious clinical signs or symptoms of liver disease [excluding nonalcoholic fatty liver disease (NAFLD)], acute or chronic hepatitis, nonalcoholic steatohepatitis (NASH), or elevated liver enzyme measurements
- Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c
- Have active or untreated cancer, have been in remission from clinically significant cancer(other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
- Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intranasal, intraocular, and inhaled preparations) or have received such therapy within the 8 weeks immediately preceding screening
- Have fasting triglycerides greater than 400 mg/dL (4.5 mmol/L) at screening
- Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night) in the investigator's opinion
- Are using or have used any of the following lipid-lowering medications: niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening
Data sourced from ClinicalTrials.gov (NCT01790438) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.