Trial Outcomes & Findings for A Study on the Effect of 2 Pen Devices on HbA1c (NCT NCT00985712)
NCT ID: NCT00985712
Last Updated: 2012-06-04
Results Overview
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean values were controlled for treatment, visit, treatment\*visit interaction, screening HbA1c (≤9% / \>9%), change of prandial insulin at baseline, and baseline HbA1c.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
263 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2012-06-04
Participant Flow
Participant milestones
| Measure |
HumaPen Luxura
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
|
HumaPen Memoir
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
133
|
130
|
|
Overall Study
Received at Least One Dose of Study Drug
|
131
|
130
|
|
Overall Study
Full Analysis Set (FAS)
|
128
|
129
|
|
Overall Study
COMPLETED
|
127
|
123
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
| Measure |
HumaPen Luxura
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
|
HumaPen Memoir
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
|
Overall Study
Sponsor decision
|
0
|
2
|
Baseline Characteristics
A Study on the Effect of 2 Pen Devices on HbA1c
Baseline characteristics by cohort
| Measure |
HumaPen Luxura
n=128 Participants
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
|
HumaPen Memoir
n=129 Participants
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
|
Total
n=257 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
41.2 years
STANDARD_DEVIATION 15.52 • n=5 Participants
|
38.3 years
STANDARD_DEVIATION 17.37 • n=7 Participants
|
39.8 years
STANDARD_DEVIATION 16.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
127 participants
n=5 Participants
|
128 participants
n=7 Participants
|
255 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
128 participants
n=5 Participants
|
129 participants
n=7 Participants
|
257 participants
n=5 Participants
|
|
Hemoglobin A1c (HbA1c)
|
9.06 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.93 • n=5 Participants
|
9.12 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.04 • n=7 Participants
|
9.09 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 0.99 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Participants in full analysis population set with missing values accounted for using mixed model repeated measures (MMRM).
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean values were controlled for treatment, visit, treatment\*visit interaction, screening HbA1c (≤9% / \>9%), change of prandial insulin at baseline, and baseline HbA1c.
Outcome measures
| Measure |
HumaPen Luxura
n=128 Participants
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
|
HumaPen Memoir
n=129 Participants
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 Endpoint
|
-0.48 percentage of glycosylated hemoglobin
Interval -0.64 to -0.32
|
-0.43 percentage of glycosylated hemoglobin
Interval -0.59 to -0.28
|
SECONDARY outcome
Timeframe: Week 24Population: Participants in full analysis population set who had Week 24 measurements.
Outcome measures
| Measure |
HumaPen Luxura
n=127 Participants
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
|
HumaPen Memoir
n=127 Participants
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
|
|---|---|---|
|
Percentage of Participants Achieving Hemoglobin A1c (HbA1c) ≤7.5% and ≤7.0% at Week 24 Endpoint
HbA1c ≤7.0%
|
5.5 percentage of participants
|
3.1 percentage of participants
|
|
Percentage of Participants Achieving Hemoglobin A1c (HbA1c) ≤7.5% and ≤7.0% at Week 24 Endpoint
HbA1c ≤7.5%
|
16.5 percentage of participants
|
11.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Participants in full analysis population set who had Week 24 measurements.
IDSQ is used to evaluate acceptance of study pen. Willingness to continue was assessed by a single question, rated from 1 to 5 (1=Definitely unwilling and 5=Definitely willing). Higher score indicates stronger desire to continue. Least Squares (LS) Mean values were controlled for treatment and baseline score.
Outcome measures
| Measure |
HumaPen Luxura
n=128 Participants
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
|
HumaPen Memoir
n=126 Participants
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
|
|---|---|---|
|
Score in Insulin Delivery System Questionnaire (IDSQ) - Willingness to Continue at Week 24 Endpoint
|
4.06 units on a scale
Interval 3.88 to 4.25
|
4.05 units on a scale
Interval 3.86 to 4.23
|
SECONDARY outcome
Timeframe: Baseline through Week 24Population: Randomized participants who took at least one dose of study drug with post-baseline hypoglycemia follow-up.
Hypoglycemic episode is defined as blood glucose measurement ≤3.9 millimoles/Liter (mmol/L; 70 milligrams/deciliter \[mg/dL\]). Adjusted rate = number of events in study period, divided by number of days in study period, then multiplied by 30.
Outcome measures
| Measure |
HumaPen Luxura
n=130 Participants
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
|
HumaPen Memoir
n=130 Participants
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
|
|---|---|---|
|
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes at Any Time From Baseline Through Week 24
|
2.68 number of events per 30 days
Standard Deviation 4.66
|
2.46 number of events per 30 days
Standard Deviation 4.38
|
SECONDARY outcome
Timeframe: Baseline through Week 24Population: Randomized participants who took at least one dose of study drug with post-baseline hyperglycemia follow-up.
Hyperglycemic episode is defined as blood glucose measurement \>18 mmol/L (324 mg/dL). Adjusted rate = number of events in study period, divided by number of days in study period, then multiplied by 30.
Outcome measures
| Measure |
HumaPen Luxura
n=130 Participants
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
|
HumaPen Memoir
n=130 Participants
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
|
|---|---|---|
|
30-Day Adjusted Rates of Self-Reported Hyperglycemic Episodes at Any Time From Baseline Through Week 24
|
2.56 number of events per 30 days
Standard Deviation 5.50
|
3.92 number of events per 30 days
Standard Deviation 9.82
|
Adverse Events
HumaPen Luxura
Serious events: 7 serious events
Other events: 52 other events
Deaths: 0 deaths
HumaPen Memoir
Serious events: 8 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HumaPen Luxura
n=131 participants at risk
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
|
HumaPen Memoir
n=130 participants at risk
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Infections and infestations
Cystitis
|
0.76%
1/131 • Number of events 1
|
0.00%
0/130
|
|
Infections and infestations
Pneumonia
|
1.5%
2/131 • Number of events 2
|
0.00%
0/130
|
|
Infections and infestations
Salpingo-oophoritis
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.00%
0/131
|
1.5%
2/130 • Number of events 2
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.76%
1/131 • Number of events 1
|
0.77%
1/130 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.5%
2/131 • Number of events 2
|
0.00%
0/130
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/131
|
0.77%
1/130 • Number of events 2
|
|
Nervous system disorders
Cerebrovascular accident
|
0.76%
1/131 • Number of events 1
|
0.00%
0/130
|
Other adverse events
| Measure |
HumaPen Luxura
n=131 participants at risk
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
|
HumaPen Memoir
n=130 participants at risk
Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.76%
1/131 • Number of events 1
|
0.00%
0/130
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
1.5%
2/131 • Number of events 2
|
0.00%
0/130
|
|
Eye disorders
Cataract
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Eye disorders
Conjunctivitis
|
0.76%
1/131 • Number of events 1
|
0.00%
0/130
|
|
Eye disorders
Glaucoma
|
0.76%
1/131 • Number of events 1
|
0.00%
0/130
|
|
Gastrointestinal disorders
Diarrhoea
|
0.76%
1/131 • Number of events 1
|
1.5%
2/130 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
0.76%
1/131 • Number of events 1
|
0.00%
0/130
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.76%
1/131 • Number of events 1
|
0.77%
1/130 • Number of events 1
|
|
General disorders
Injection site pain
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
General disorders
Oedema
|
0.76%
1/131 • Number of events 1
|
0.00%
0/130
|
|
General disorders
Oedema peripheral
|
1.5%
2/131 • Number of events 2
|
0.00%
0/130
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.76%
1/131 • Number of events 1
|
0.77%
1/130 • Number of events 1
|
|
Infections and infestations
Cystitis
|
1.5%
2/131 • Number of events 2
|
0.00%
0/130
|
|
Infections and infestations
Ear infection
|
0.00%
0/131
|
0.77%
1/130 • Number of events 2
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.76%
1/131 • Number of events 1
|
0.00%
0/130
|
|
Infections and infestations
Fungal infection
|
0.76%
1/131 • Number of events 1
|
0.00%
0/130
|
|
Infections and infestations
Gastroenteritis
|
0.76%
1/131 • Number of events 1
|
1.5%
2/130 • Number of events 2
|
|
Infections and infestations
Infection
|
0.76%
1/131 • Number of events 1
|
0.00%
0/130
|
|
Infections and infestations
Influenza
|
0.76%
1/131 • Number of events 1
|
0.77%
1/130 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
11.5%
15/131 • Number of events 18
|
9.2%
12/130 • Number of events 13
|
|
Infections and infestations
Pneumonia
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Infections and infestations
Scarlet fever
|
0.76%
1/131 • Number of events 1
|
0.00%
0/130
|
|
Infections and infestations
Sinobronchitis
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Infections and infestations
Tonsillitis
|
1.5%
2/131 • Number of events 2
|
0.77%
1/130 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
2.3%
3/131 • Number of events 3
|
1.5%
2/130 • Number of events 2
|
|
Infections and infestations
Viral infection
|
0.76%
1/131 • Number of events 1
|
0.77%
1/130 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint sprain
|
1.5%
2/131 • Number of events 2
|
0.77%
1/130 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.76%
1/131 • Number of events 1
|
0.77%
1/130 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound
|
1.5%
2/131 • Number of events 2
|
0.00%
0/130
|
|
Investigations
Liver function test abnormal
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.76%
1/131 • Number of events 1
|
1.5%
2/130 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.76%
1/131 • Number of events 1
|
0.77%
1/130 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.76%
1/131 • Number of events 1
|
0.77%
1/130 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
3/131 • Number of events 3
|
0.00%
0/130
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.76%
1/131 • Number of events 1
|
0.00%
0/130
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Nervous system disorders
Headache
|
1.5%
2/131 • Number of events 2
|
0.00%
0/130
|
|
Nervous system disorders
Migraine
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Nervous system disorders
Polyneuropathy
|
0.76%
1/131 • Number of events 1
|
0.00%
0/130
|
|
Psychiatric disorders
Anxiety
|
0.76%
1/131 • Number of events 1
|
0.00%
0/130
|
|
Psychiatric disorders
Burnout syndrome
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Psychiatric disorders
Depression
|
1.5%
2/131 • Number of events 2
|
0.00%
0/130
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.76%
1/131 • Number of events 1
|
0.77%
1/130 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.76%
1/131 • Number of events 1
|
0.00%
0/130
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.76%
1/131 • Number of events 1
|
0.00%
0/130
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.76%
1/131 • Number of events 1
|
0.00%
0/130
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Lipodystrophy acquired
|
1.5%
2/131 • Number of events 2
|
0.00%
0/130
|
|
Skin and subcutaneous tissue disorders
Lipohypertrophy
|
0.76%
1/131 • Number of events 1
|
0.00%
0/130
|
|
Skin and subcutaneous tissue disorders
Neuropathic ulcer
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.76%
1/131 • Number of events 1
|
0.00%
0/130
|
|
Vascular disorders
Haematoma
|
0.76%
1/131 • Number of events 1
|
0.00%
0/130
|
|
Vascular disorders
Hypertension
|
0.76%
1/131 • Number of events 1
|
0.00%
0/130
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/131
|
0.77%
1/130 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60