A Phase 4 interventional study of biphasic insulin aspart 30 and biphasic insulin aspart 30 in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-30.
Sponsored by Novo Nordisk A/S · Phase 4, Interventional, and Treatment
This trial is conducted in Asia. The aim of this trial is to compare the glycaemic control when subjects initiate a biphasic insulin aspart 30 treatment followed by an intensified treatment if treatment target of HbA1c below 7% is not reached by OAD (oral anti-diabetic drugs) alone.
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This study's enrollment of 245 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Drug: biphasic insulin aspart 30
Drug: biphasic insulin aspart 30
Administered subcutaneously (under the skin) once daily, before breakfast. The trial has 3 treatment phases for both treatment arms
Administered subcutaneously (under the skin) once daily, before dinner. The trial has 3 treatment phases for both treatment arms
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11
Estimated mean change from baseline in HbA1c after 11 weeks of treatment
Time frame: Week 0, Week 11
Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36
Estimated mean change from baseline in FPG after 36 weeks of treatment
Time frame: Week 0, Week 36
Number of Treatment Emergent Hypoglycaemic Episodes
A hypoglycaemic episode will be defined as treatment emergent if the onset of the episode is on or after the first day of trial product, and no later than the last day on trial product.
Time frame: Week 0 to Week 36
The trial was conducted at 5 sites in Iran
| Milestone | Pre-breakfast BIAsp 30 | Pre-dinner BIAsp 30 |
|---|---|---|
| Started | 122 | 123 |
| Completed | 103 | 107 |
| Not completed | 19 | 16 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Protocol violation | 2 | 0 |
| Withdrew: Withdrawal criteria | 8 | 11 |
| Withdrew: Lost to follow-up | 3 | 0 |
| Withdrew: Unclassified | 5 | 5 |
Estimated mean change from baseline in HbA1c after 11 weeks of treatment
| percentage of glycosylated haemoglobin | Pre-breakfast BIAsp 30 | Pre-dinner BIAsp 30 |
|---|---|---|
| Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11 | -1.04 ± 0.10 | -0.90 ± 0.10 |
Estimated mean change from baseline in FPG after 36 weeks of treatment
| mg/dL | Pre-breakfast BIAsp 30 | Pre-dinner BIAsp 30 |
|---|---|---|
| Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36 | -61.57 ± 4.50 | -58.43 ± 4.48 |
A hypoglycaemic episode will be defined as treatment emergent if the onset of the episode is on or after the first day of trial product, and no later than the last day on trial product.
| episodes | Pre-breakfast BIAsp 30 | Pre-dinner BIAsp 30 |
|---|---|---|
| Number of Treatment Emergent Hypoglycaemic Episodes | 1181 | 953 |
Collected over The adverse events were collected in a timeframe of 36 weeks +14 days follow-up.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pre-breakfast BIAsp 30 | — | 3/122 (2.5%) | 16/122 (13.1%) |
| Pre-dinner BIAsp 30 | — | 4/123 (3.3%) | 19/123 (15.4%) |
| Event | Pre-breakfast BIAsp 30 | Pre-dinner BIAsp 30 |
|---|---|---|
| Angina unstableCardiac disorders | 2/122 | 0/123 |
| Coronary artery diseaseCardiac disorders | 1/122 | 1/123 |
| CholecystitisHepatobiliary disorders | 0/122 | 1/123 |
| Hip fractureInjury, poisoning and procedural complications | 0/122 | 1/123 |
| HypoglycaemiaMetabolism and nutrition disorders | 0/122 | 1/123 |
| Event | Pre-breakfast BIAsp 30 | Pre-dinner BIAsp 30 |
|---|---|---|
| HyperlipidaemiaMetabolism and nutrition disorders | 9/122 | 11/123 |
| NasopharyngitisInfections and infestations | 7/122 | 8/123 |
| Age, Continuous(years) | Pre-breakfast BIAsp 30 | Pre-dinner BIAsp 30 | Total |
|---|---|---|---|
| Mean | 55.6 ± 9.32 | 54.8 ± 10.32 | 55.2 ± 9.82 |
| Sex: Female, Male(Participants) | Pre-breakfast BIAsp 30 | Pre-dinner BIAsp 30 | Total |
|---|---|---|---|
| Female | 72 | 74 | 146 |
| Male | 50 | 49 | 99 |
| Glycosylated haemoglobin (HbA1c)(percentage of glycosylated haemoglobin) | Pre-breakfast BIAsp 30 | Pre-dinner BIAsp 30 | Total |
|---|---|---|---|
| Mean | 9.1 ± 1.07 | 9.2 ± 1.00 | 9.2 ± 1.04 |
| Fasting plasma glucose (FPG)(mg/dL) | Pre-breakfast BIAsp 30 | Pre-dinner BIAsp 30 | Total |
|---|---|---|---|
| Mean | 192.7 ± 68.56 | 199.3 ± 63.80 | 196.0 ± 66.16 |
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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