Trial Outcomes & Findings for A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog® (NCT NCT00356421)
NCT ID: NCT00356421
Last Updated: 2009-09-02
Results Overview
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
TERMINATED
PHASE4
58 participants
At 52 weeks
2009-09-02
Participant Flow
A total of 340 subjects were planned to be randomized; 87 were screened and 58 were randomized to study treatment prior to study termination.
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study.
Participant milestones
| Measure |
Exubera ®
Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
|
Insulin Lispro
Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
20
|
|
Overall Study
COMPLETED
|
6
|
3
|
|
Overall Study
NOT COMPLETED
|
32
|
17
|
Reasons for withdrawal
| Measure |
Exubera ®
Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
|
Insulin Lispro
Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
9
|
2
|
|
Overall Study
Related to study drug
|
15
|
12
|
|
Overall Study
Not related to study drug
|
5
|
3
|
Baseline Characteristics
A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog®
Baseline characteristics by cohort
| Measure |
Exubera ®
n=38 Participants
Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
|
Insulin Lispro
n=20 Participants
Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 - 44 years
|
22 participants
n=5 Participants
|
13 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Age, Customized
45 - 64 years
|
14 participants
n=5 Participants
|
6 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 52 weeksPopulation: Intent to Treat (ITT) population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 52 weeksPopulation: ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 52 weeksPopulation: ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At weeks 2, 4, 6, 12, 24, 36, and 52 or last observation.Population: ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 52 weeks or last observationPopulation: ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: To 52 weeksPopulation: ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: To 52 weeksPopulation: ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At weeks 24 and 52 or last observation.Population: ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At weeks 12, 24, 36, and 52 or last observation.Population: ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At weeks 12, 24, 36, and 52 or last observation.Population: ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: To 52 weeksPopulation: ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: To 52 weeksPopulation: ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: To 52 weeks.Population: ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At weeks 24 and 52 or last observationPopulation: ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At weeks 6, 24, and 52 or last observationPopulation: ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At weeks 6, 24, and 52 or last observationPopulation: ITT population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
Outcome measures
Outcome data not reported
Adverse Events
Exubera ®
Insulin Lispro
Serious adverse events
| Measure |
Exubera ®
Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
|
Insulin Lispro
Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
|
|---|---|---|
|
Investigations
Blood creatinine increased
|
2.6%
1/38
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.3%
2/38
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
2.6%
1/38
|
5.0%
1/20
|
Other adverse events
| Measure |
Exubera ®
Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
|
Insulin Lispro
Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/38
|
5.0%
1/20
|
|
Ear and labyrinth disorders
Vertigo
|
2.6%
1/38
|
0.00%
0/20
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/38
|
5.0%
1/20
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
2.6%
1/38
|
0.00%
0/20
|
|
Gastrointestinal disorders
Dyspepsia
|
2.6%
1/38
|
0.00%
0/20
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/38
|
5.0%
1/20
|
|
Gastrointestinal disorders
Nausea
|
5.3%
2/38
|
5.0%
1/20
|
|
Gastrointestinal disorders
Vomiting
|
7.9%
3/38
|
10.0%
2/20
|
|
General disorders
Asthenia
|
2.6%
1/38
|
0.00%
0/20
|
|
General disorders
Chest pain
|
0.00%
0/38
|
5.0%
1/20
|
|
General disorders
Drug intolerance
|
2.6%
1/38
|
0.00%
0/20
|
|
General disorders
Fatigue
|
0.00%
0/38
|
5.0%
1/20
|
|
General disorders
Hunger
|
5.3%
2/38
|
0.00%
0/20
|
|
General disorders
Malaise
|
5.3%
2/38
|
0.00%
0/20
|
|
General disorders
Pyrexia
|
0.00%
0/38
|
5.0%
1/20
|
|
Infections and infestations
Balanitis candida
|
0.00%
0/38
|
5.0%
1/20
|
|
Infections and infestations
Ear infection
|
2.6%
1/38
|
0.00%
0/20
|
|
Infections and infestations
Gastroenteritis
|
7.9%
3/38
|
5.0%
1/20
|
|
Infections and infestations
Gastrointestinal infection
|
2.6%
1/38
|
0.00%
0/20
|
|
Infections and infestations
Influenza
|
5.3%
2/38
|
5.0%
1/20
|
|
Infections and infestations
Localised infection
|
5.3%
2/38
|
0.00%
0/20
|
|
Infections and infestations
Nasopharyngitis
|
23.7%
9/38
|
35.0%
7/20
|
|
Infections and infestations
Onychomycosis
|
2.6%
1/38
|
0.00%
0/20
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/38
|
10.0%
2/20
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/38
|
10.0%
2/20
|
|
Infections and infestations
Respiratory tract infection viral
|
2.6%
1/38
|
0.00%
0/20
|
|
Infections and infestations
Sinusitis
|
5.3%
2/38
|
0.00%
0/20
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/38
|
5.0%
1/20
|
|
Infections and infestations
Tracheitis
|
2.6%
1/38
|
0.00%
0/20
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/38
|
5.0%
1/20
|
|
Infections and infestations
Vaginal candidiasis
|
2.6%
1/38
|
0.00%
0/20
|
|
Infections and infestations
Viral pharyngitis
|
2.6%
1/38
|
0.00%
0/20
|
|
Infections and infestations
Vulvovaginitis
|
2.6%
1/38
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
Eye injury
|
2.6%
1/38
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
Fall
|
2.6%
1/38
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/38
|
5.0%
1/20
|
|
Injury, poisoning and procedural complications
Thermal burn
|
2.6%
1/38
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
Wound
|
2.6%
1/38
|
0.00%
0/20
|
|
Investigations
Alanine aminotransferase increased
|
2.6%
1/38
|
0.00%
0/20
|
|
Investigations
Weight decreased
|
2.6%
1/38
|
0.00%
0/20
|
|
Investigations
Weight increased
|
2.6%
1/38
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Anorexia
|
2.6%
1/38
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.3%
2/38
|
5.0%
1/20
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
86.8%
33/38
|
90.0%
18/20
|
|
Metabolism and nutrition disorders
Polydipsia
|
2.6%
1/38
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
2/38
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
2/38
|
5.0%
1/20
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.6%
1/38
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.6%
1/38
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/38
|
5.0%
1/20
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.6%
1/38
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
2.6%
1/38
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.6%
1/38
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
2.6%
1/38
|
0.00%
0/20
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/38
|
5.0%
1/20
|
|
Nervous system disorders
Disturbance in attention
|
2.6%
1/38
|
0.00%
0/20
|
|
Nervous system disorders
Dizziness
|
5.3%
2/38
|
0.00%
0/20
|
|
Nervous system disorders
Headache
|
10.5%
4/38
|
5.0%
1/20
|
|
Nervous system disorders
Somnolence
|
2.6%
1/38
|
0.00%
0/20
|
|
Nervous system disorders
Tremor
|
2.6%
1/38
|
0.00%
0/20
|
|
Psychiatric disorders
Depression
|
2.6%
1/38
|
0.00%
0/20
|
|
Psychiatric disorders
Disorientation
|
2.6%
1/38
|
0.00%
0/20
|
|
Psychiatric disorders
Mental disorder
|
2.6%
1/38
|
0.00%
0/20
|
|
Renal and urinary disorders
Ketonuria
|
0.00%
0/38
|
5.0%
1/20
|
|
Renal and urinary disorders
Polyuria
|
2.6%
1/38
|
0.00%
0/20
|
|
Reproductive system and breast disorders
Endometriosis
|
2.6%
1/38
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.2%
5/38
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.6%
1/38
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/38
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
2.6%
1/38
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal discomfort
|
0.00%
0/38
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.3%
2/38
|
10.0%
2/20
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/38
|
5.0%
1/20
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.3%
2/38
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
10.5%
4/38
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.6%
1/38
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/38
|
5.0%
1/20
|
|
Vascular disorders
Haematoma
|
2.6%
1/38
|
5.0%
1/20
|
|
Vascular disorders
Hot flush
|
2.6%
1/38
|
0.00%
0/20
|
|
Vascular disorders
Hypertensive crisis
|
2.6%
1/38
|
0.00%
0/20
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \<60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \<12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
- Publication restrictions are in place
Restriction type: OTHER