Diabetes Mellitus Type 2
Conditions
Keywords
Type 2 diabetes melllitus
Brief summary
To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents
Interventions
Addition of inhaled insulin to pre-existing oral diabetes therapy.
OTHERStandard of Care
Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diabetes mellitus type 2 * Failing two or more oral anti-diabetic agents
Exclusion criteria
* Asthma, COPD * Smoking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | 4, 12 and 24 weeks | \[(week 24 value - baseline value)/baseline value\]\*100% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Glycemic Control by Visit | 4, 12 and 24 weeks | 2 definitions of good glycemic control were used: an HbA1c result of ≤6.5% or ≤7.0% |
| Change From Baseline in FEV1 at Week 24 LOCF | 24 weeks | — |
Countries
Canada, France, Greece, Portugal, Spain, Sweden, Turkey (Türkiye)
Participant flow
Pre-assignment details
Total subjects enrolled=354. Total subjects given study drug=351. (ie, 3 subjects withdrew after enrollment/randomization, but prior to receiving study drug)
Participants by arm
| Arm | Count |
|---|---|
| Inhaled Insulin Inhaled insulin plus oral therapy | 180 |
| Standard of Care Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators | 171 |
| Total | 351 |
Baseline characteristics
| Characteristic | Inhaled Insulin | Standard of Care | Total |
|---|---|---|---|
| Age, Customized <18 years | 0 participants | 0 participants | 0 participants |
| Age, Customized >=65 years | 56 participants | 52 participants | 108 participants |
| Age, Customized Between 18 and 44 years | 12 participants | 6 participants | 18 participants |
| Age, Customized Between 45 and 64 years | 112 participants | 113 participants | 225 participants |
| Sex: Female, Male Female | 76 Participants | 80 Participants | 156 Participants |
| Sex: Female, Male Male | 104 Participants | 91 Participants | 195 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 123 / 180 | 98 / 171 |
| serious Total, serious adverse events | 8 / 180 | 6 / 171 |
Outcome results
Primary
Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
\[(week 24 value - baseline value)/baseline value\]\*100%
Time frame: 4, 12 and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Inhaled Insulin | 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 |
| Inhaled Insulin | 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 |
| Inhaled Insulin | 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 |
| Inhaled Insulin | Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | week 24 (n=142 and 150, respectively) | -2.02 percentage change | Standard Deviation 1.1 |
| Standard of Care | Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | week 24 (LOCF, n=175 and 170, respectively) | -1.42 percentage change | Standard Deviation 1.09 |
| Standard of Care | Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | week 4 (n=164 and 158, respectively) | -0.62 percentage change | Standard Deviation 0.55 |
| Standard of Care | Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | week 12 (n=159 and 150, respectively) | -1.37 percentage change | Standard Deviation 0.92 |
| Standard of Care | Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | week 24 (n=142 and 150, respectively) | -1.44 percentage change | Standard Deviation 1.1 |
Secondary
Change From Baseline in FEV1 at Week 24 LOCF
Time frame: 24 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inhaled Insulin | Change From Baseline in FEV1 at Week 24 LOCF | -0.27 Liter | Standard Deviation 9.85 |
| Standard of Care | Change From Baseline in FEV1 at Week 24 LOCF | -0.08 Liter | Standard Deviation 0.61 |
Secondary
Percentage of Participants Achieving Glycemic Control by Visit
2 definitions of good glycemic control were used: an HbA1c result of ≤6.5% or ≤7.0%
Time frame: 4, 12 and 24 weeks
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Inhaled Insulin | Percentage of Participants Achieving Glycemic Control by Visit | HbA1c<=7% at week 4 (n=165 and 158 respectively) | 6.1 Percentage of participants |
| Inhaled Insulin | Percentage of Participants Achieving Glycemic Control by Visit | HbA1c<=7% at week 12 (n=160 and 150 respectively) | 38.1 Percentage of participants |
| Inhaled Insulin | Percentage of Participants Achieving Glycemic Control by Visit | HbA1c<=7% at week 24 (n=143 and 150 respectively) | 34.3 Percentage of participants |
| Inhaled Insulin | Percentage of Participants Achieving Glycemic Control by Visit | HbA1c<=7% at wk-24 LOCF (n=178 & 170 respectively) | 32.0 Percentage of participants |
| Inhaled Insulin | Percentage of Participants Achieving Glycemic Control by Visit | HbA1c<=6.5% at week 4 (n=165 and 158 respectively) | 0.6 Percentage of participants |
| Inhaled Insulin | Percentage of Participants Achieving Glycemic Control by Visit | HbA1c<=6.5% at week 12 (n=160 &150 respectively) | 15.6 Percentage of participants |
| Inhaled Insulin | Percentage of Participants Achieving Glycemic Control by Visit | HbA1c<=6.5% at week 24 (n=143 &150 respectively) | 18.2 Percentage of participants |
| Inhaled Insulin | Percentage of Participants Achieving Glycemic Control by Visit | HbA1c<=6.5% at wk-24 LOCF(n=178 &170 respectively) | 15.2 Percentage of participants |
| Standard of Care | Percentage of Participants Achieving Glycemic Control by Visit | HbA1c<=6.5% at wk-24 LOCF(n=178 &170 respectively) | 5.9 Percentage of participants |
| Standard of Care | Percentage of Participants Achieving Glycemic Control by Visit | HbA1c<=7% at week 4 (n=165 and 158 respectively) | 0.0 Percentage of participants |
| Standard of Care | Percentage of Participants Achieving Glycemic Control by Visit | HbA1c<=6.5% at week 4 (n=165 and 158 respectively) | 0.0 Percentage of participants |
| Standard of Care | Percentage of Participants Achieving Glycemic Control by Visit | HbA1c<=7% at week 12 (n=160 and 150 respectively) | 11.3 Percentage of participants |
| Standard of Care | Percentage of Participants Achieving Glycemic Control by Visit | HbA1c<=6.5% at week 24 (n=143 &150 respectively) | 6.0 Percentage of participants |
| Standard of Care | Percentage of Participants Achieving Glycemic Control by Visit | HbA1c<=7% at week 24 (n=143 and 150 respectively) | 12.0 Percentage of participants |
| Standard of Care | Percentage of Participants Achieving Glycemic Control by Visit | HbA1c<=6.5% at week 12 (n=160 &150 respectively) | 4.7 Percentage of participants |
| Standard of Care | Percentage of Participants Achieving Glycemic Control by Visit | HbA1c<=7% at wk-24 LOCF (n=178 & 170 respectively) | 12.9 Percentage of participants |