Trial Outcomes & Findings for A Clinical Trial Assessing The Impact Of Inhaled Insulin On Glucose Control In Patients With Type 2 Diabetes Mellitus (NCT NCT00282971)
NCT ID: NCT00282971
Last Updated: 2019-04-02
Results Overview
\[(week 24 value - baseline value)/baseline value\]\*100%
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
354 participants
Primary outcome timeframe
4, 12 and 24 weeks
Results posted on
2019-04-02
Participant Flow
Total subjects enrolled=354. Total subjects given study drug=351. (ie, 3 subjects withdrew after enrollment/randomization, but prior to receiving study drug)
Participant milestones
| Measure |
Inhaled Insulin
Inhaled insulin plus oral therapy
|
Standard of Care
Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
|
|---|---|---|
|
Overall Study
STARTED
|
180
|
171
|
|
Overall Study
COMPLETED
|
146
|
149
|
|
Overall Study
NOT COMPLETED
|
34
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Trial Assessing The Impact Of Inhaled Insulin On Glucose Control In Patients With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Inhaled Insulin
n=180 Participants
Inhaled insulin plus oral therapy
|
Standard of Care
n=171 Participants
Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
|
Total
n=351 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<18 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Customized
Between 18 and 44 years
|
12 participants
n=5 Participants
|
6 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Age, Customized
Between 45 and 64 years
|
112 participants
n=5 Participants
|
113 participants
n=7 Participants
|
225 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
56 participants
n=5 Participants
|
52 participants
n=7 Participants
|
108 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4, 12 and 24 weeksPopulation: Out of 180 and 171 subjects that were treated with study drug and usual care, respectively, the Full Analysis Set (FAS)for each group which was analyzed for efficacy, was 179 and 170 subjects, respectively.
\[(week 24 value - baseline value)/baseline value\]\*100%
Outcome measures
| Measure |
Inhaled Insulin
n=179 Participants
Inhaled insulin plus oral therapy
|
Standard of Care
n=170 Participants
Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
|
|---|---|---|
|
Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
week 4 (n=164 and 158, respectively)
|
-1.08 percentage change
Standard Deviation 0.61
|
-0.62 percentage change
Standard Deviation 0.55
|
|
Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
week 12 (n=159 and 150, respectively)
|
-2.03 percentage change
Standard Deviation 0.97
|
-1.37 percentage change
Standard Deviation 0.92
|
|
Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
week 24 (n=142 and 150, respectively)
|
-2.02 percentage change
Standard Deviation 1.10
|
-1.44 percentage change
Standard Deviation 1.10
|
|
Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
week 24 (LOCF, n=175 and 170, respectively)
|
-1.94 percentage change
Standard Deviation 1.09
|
-1.42 percentage change
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: 4, 12 and 24 weeksPopulation: Out of 180 and 171 subjects that were treated with study drug and usual care, respectively, the Full Analysis Set (FAS)for each group which was analyzed for efficacy, was 179 and 170 subjects, respectively. LOCF=last observation carried forward.
2 definitions of good glycemic control were used: an HbA1c result of ≤6.5% or ≤7.0%
Outcome measures
| Measure |
Inhaled Insulin
n=179 Participants
Inhaled insulin plus oral therapy
|
Standard of Care
n=170 Participants
Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
|
|---|---|---|
|
Percentage of Participants Achieving Glycemic Control by Visit
HbA1c<=6.5% at week 12 (n=160 &150 respectively)
|
15.6 Percentage of participants
|
4.7 Percentage of participants
|
|
Percentage of Participants Achieving Glycemic Control by Visit
HbA1c<=6.5% at week 24 (n=143 &150 respectively)
|
18.2 Percentage of participants
|
6.0 Percentage of participants
|
|
Percentage of Participants Achieving Glycemic Control by Visit
HbA1c<=6.5% at wk-24 LOCF(n=178 &170 respectively)
|
15.2 Percentage of participants
|
5.9 Percentage of participants
|
|
Percentage of Participants Achieving Glycemic Control by Visit
HbA1c<=7% at week 4 (n=165 and 158 respectively)
|
6.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Achieving Glycemic Control by Visit
HbA1c<=7% at week 12 (n=160 and 150 respectively)
|
38.1 Percentage of participants
|
11.3 Percentage of participants
|
|
Percentage of Participants Achieving Glycemic Control by Visit
HbA1c<=7% at week 24 (n=143 and 150 respectively)
|
34.3 Percentage of participants
|
12.0 Percentage of participants
|
|
Percentage of Participants Achieving Glycemic Control by Visit
HbA1c<=7% at wk-24 LOCF (n=178 & 170 respectively)
|
32.0 Percentage of participants
|
12.9 Percentage of participants
|
|
Percentage of Participants Achieving Glycemic Control by Visit
HbA1c<=6.5% at week 4 (n=165 and 158 respectively)
|
0.6 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Out of 180 and 171 subjects that were treated with study drug and usual care, respectively, the Full Analysis Set (FAS)for each group which was analyzed for efficacy, was 179 and 170 subjects, respectively.FEV1=forced expiratory volume in 1 second;LOCF=last observation carried forward.
Outcome measures
| Measure |
Inhaled Insulin
n=179 Participants
Inhaled insulin plus oral therapy
|
Standard of Care
n=170 Participants
Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
|
|---|---|---|
|
Change From Baseline in FEV1 at Week 24 LOCF
|
-0.27 Liter
Standard Deviation 9.85
|
-0.08 Liter
Standard Deviation 0.61
|
Adverse Events
Inhaled Insulin
Serious events: 8 serious events
Other events: 123 other events
Deaths: 0 deaths
Standard of Care
Serious events: 6 serious events
Other events: 98 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Inhaled Insulin
n=180 participants at risk
Inhaled insulin plus oral therapy
|
Standard of Care
n=171 participants at risk
Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.56%
1/180
|
0.00%
0/171
|
|
Cardiac disorders
Cardiac failure
|
0.56%
1/180
|
0.00%
0/171
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/180
|
0.58%
1/171
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/180
|
0.58%
1/171
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/180
|
0.58%
1/171
|
|
General disorders
Oedema peripheral
|
0.56%
1/180
|
0.00%
0/171
|
|
Hepatobiliary disorders
Cholecystitis
|
0.56%
1/180
|
0.00%
0/171
|
|
Infections and infestations
Incision site cellulitis
|
0.56%
1/180
|
0.00%
0/171
|
|
Injury, poisoning and procedural complications
Device malfunction
|
0.56%
1/180
|
0.00%
0/171
|
|
Investigations
Blood glucose increase
|
0.56%
1/180
|
0.00%
0/171
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/180
|
0.58%
1/171
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.56%
1/180
|
0.58%
1/171
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/180
|
0.58%
1/171
|
|
Nervous system disorders
Cerebrovascular accident
|
0.56%
1/180
|
0.00%
0/171
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/180
|
0.58%
1/171
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.56%
1/180
|
0.00%
0/171
|
Other adverse events
| Measure |
Inhaled Insulin
n=180 participants at risk
Inhaled insulin plus oral therapy
|
Standard of Care
n=171 participants at risk
Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
2/180
|
2.3%
4/171
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
4/180
|
1.8%
3/171
|
|
General disorders
Asthenia
|
2.8%
5/180
|
3.5%
6/171
|
|
General disorders
Fatigue
|
2.2%
4/180
|
1.8%
3/171
|
|
General disorders
Pyrexia
|
2.2%
4/180
|
0.58%
1/171
|
|
Infections and infestations
Bronchitis
|
2.8%
5/180
|
1.2%
2/171
|
|
Infections and infestations
Influenza
|
3.3%
6/180
|
4.1%
7/171
|
|
Infections and infestations
Nasopharyngitis
|
4.4%
8/180
|
2.3%
4/171
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
5/180
|
2.9%
5/171
|
|
Infections and infestations
Urinary tract infection
|
3.9%
7/180
|
3.5%
6/171
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
65.6%
118/180
|
57.3%
98/171
|
|
Nervous system disorders
Dizziness
|
3.3%
6/180
|
1.8%
3/171
|
|
Nervous system disorders
Headache
|
1.1%
2/180
|
3.5%
6/171
|
|
Nervous system disorders
Tremor
|
4.4%
8/180
|
2.9%
5/171
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
10/180
|
1.2%
2/171
|
|
Vascular disorders
Hypertension
|
1.1%
2/180
|
2.3%
4/171
|
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