Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| F3Z-GH-IOPA |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare glycemic control (HbA1c) in Chinese patients with type 1 or type 2 diabetes when treated with insulin lispro low mixture and human insulin 30/70.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Human insulin mix 30/70 |
|
| 2 | Experimental | Insulin lispro low mix |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human insulin 30/70 | Drug | Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint | Glycosylated hemoglobin reflects the average blood glucose level over the previous 12 weeks of treatment. | Baseline and 12 weeks of each treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Glycosylated Hemoglobin (HbA1c) From Baseline to 12 Weeks of Treatment | Changes in glycosylated hemoglobin reflect the change in average blood glucose level between baseline and 12 weeks of treatment. Change = Baseline - Endpoint. | Baseline and at 12 weeks of each treatment |
| Change in Fasting Blood Glucose Values From Baseline to 12 Weeks of Treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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. | Guangzhou | 510120 |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Human Insulin Mix 30/70 First, Then Insulin Lispro Low Mix | Human insulin mix 30/70 for 12 weeks followed by insulin lispro low mix for 12 weeks |
| FG001 | Insulin Lispro Low Mix First, Then Human Insulin Mix 30/70 | Insulin lispro low mix for 12 weeks followed by human insulin mix 30/70 for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Human Insulin Mix 30/70 First, Then Insulin Lispro Low Mix | Human insulin mix 30/70 for 12 weeks followed by insulin lispro low mix for 12 weeks |
| BG001 | Insulin Lispro Low Mix First, Then Human Insulin Mix 30/70 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint | Glycosylated hemoglobin reflects the average blood glucose level over the previous 12 weeks of treatment. | Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed. | Posted | Mean | 95% Confidence Interval | percent of glycosylated hemoglobin | Baseline and 12 weeks of each treatment |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Human Insulin Mix 30/70 | Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 1-800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Insulin lispro low mix | Drug | Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks |
|
|
Values obtained after at least an 8 hour fast. Change = Baseline - Endpoint |
| Baseline and 12 weeks of each treatment |
| Change in Total Daily Insulin Dose Values From Baseline to 12 Weeks of Treatment | Insulin lispro low mix was to be administered within 15 minutes of morning and evening meals. Human insulin mix 30/70 was to be administered within 30 minutes of morning and evening meals. Change = Baseline - Endpoint | Baseline and 12 weeks of each treatment |
| Number of Participants Achieving Target Glycosylated Hemoglobin (HbA1c) Values <=7% and <=6.5% | Number of patients in each treatment group achieving the target HbA1c value during 12 weeks of each treatment. | 12 weeks of each treatment |
| Number of Participants With Laboratory Parameters Significantly Different From Baseline | Number of participants with laboratory parameters (hematology, chemistry, and urinalysis) that were significantly different from baseline after 12 weeks of each treatment. | Baseline and 12 weeks of each treatment |
| Hypoglycemia Rate Per Participant Per 30 Days | Hypoglycemia rate per patient per 30 days = (number of reported hypogylcemia events/number of days within the period) * 30 days. Since this was a 2x2 cross-over design (2 treatments and 2 periods), then the hypogyclemia rate was calculated per patient for each of the 2 periods by treatment. | over 12 weeks of each treatment period |
| China |
| 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. | Hangzhou | 310003 | China |
| 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. | Harbin | 150086 | China |
| 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. | Hefei | 230022 | China |
| Lost to Follow-up |
|
Insulin lispro low mix for 12 weeks followed by human insulin mix 30/70 for 12 weeks
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Other Treatments for Diabetes Prior to Study | Number | participants |
|
| Race/Ethnicity | Number | participants |
|
| Type of Diabetes | Number | participants |
|
| Baseline Fasting Blood Glucose | Mean | Standard Deviation | millimole/Liter |
|
| Baseline Glycosylated Hemoglobin | Mean | Standard Deviation | percent of glycosylated hemoglobin |
|
| Body Mass Index | Body mass index is an estimate of body fat based on body weight divided by body height squared. | Mean | Standard Deviation | kilogram per meter squared |
|
| Duration of Diabetes | Mean | Standard Deviation | months |
|
| Duration of Insulin Treatment | Mean | Standard Deviation | months |
|
Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks. |
|
|
|
| Secondary | Changes in Glycosylated Hemoglobin (HbA1c) From Baseline to 12 Weeks of Treatment | Changes in glycosylated hemoglobin reflect the change in average blood glucose level between baseline and 12 weeks of treatment. Change = Baseline - Endpoint. | Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed. | Posted | Mean | 95% Confidence Interval | percent of glycosylated hemoglobin | Baseline and at 12 weeks of each treatment |
|
|
|
|
| Secondary | Change in Fasting Blood Glucose Values From Baseline to 12 Weeks of Treatment | Values obtained after at least an 8 hour fast. Change = Baseline - Endpoint | Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed. LOCF within each period. | Posted | Mean | 95% Confidence Interval | millimoles/Liter | Baseline and 12 weeks of each treatment |
|
|
|
|
| Secondary | Change in Total Daily Insulin Dose Values From Baseline to 12 Weeks of Treatment | Insulin lispro low mix was to be administered within 15 minutes of morning and evening meals. Human insulin mix 30/70 was to be administered within 30 minutes of morning and evening meals. Change = Baseline - Endpoint | Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed. LOCF within each period. | Posted | Mean | 95% Confidence Interval | units of insulin | Baseline and 12 weeks of each treatment |
|
|
|
|
| Secondary | Number of Participants Achieving Target Glycosylated Hemoglobin (HbA1c) Values <=7% and <=6.5% | Number of patients in each treatment group achieving the target HbA1c value during 12 weeks of each treatment. | Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed. | Posted | Number | participants | 12 weeks of each treatment |
|
|
|
|
| Secondary | Number of Participants With Laboratory Parameters Significantly Different From Baseline | Number of participants with laboratory parameters (hematology, chemistry, and urinalysis) that were significantly different from baseline after 12 weeks of each treatment. | Includes all randomized patients receiving at least one dose. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed. | Posted | Number | participants | Baseline and 12 weeks of each treatment |
|
|
|
| Secondary | Hypoglycemia Rate Per Participant Per 30 Days | Hypoglycemia rate per patient per 30 days = (number of reported hypogylcemia events/number of days within the period) * 30 days. Since this was a 2x2 cross-over design (2 treatments and 2 periods), then the hypogyclemia rate was calculated per patient for each of the 2 periods by treatment. | Includes all randomized patients who had at least one dose. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed. | Posted | Mean | 95% Confidence Interval | events/30 days | over 12 weeks of each treatment period |
|
|
|
|
| 2 |
| 19 |
| EG001 | Insulin Lispro Low Mix | Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks. | 1 | 23 |
| Cerebrovascular accident | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Hypoglycemic coma | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Lacunar infarction | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 10.0 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 10.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
|
| Diabetic nephropathy | Renal and urinary disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
|
Not provided
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
P-value for the HbA1c Percentage Criteria (6.5%) |
| 95 |
| No |
| Superiority or Other |
| Urinalysis - Significantly Different from Baseline |
|