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Veterans Inpatient Insulin Study and Transition to Outpatient Therapy
Phase 4 trial testing NPH/Regular 70/30 mix in Type 2 Diabetes Mellitus in 120 participants. Completed in 23 April 2013.
| Lead sponsor | Dennis G. Karounos, M.D. |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 11 March 2009 |
| Primary completion | 23 April 2013 |
| Estimated completion | 23 April 2013 |
| Sites | 1 location across United States |
Dennis G. Karounos, M.D. — full company profile →
40 and older, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Hemoglobin A1c
| Group | Value | 95% CI |
|---|---|---|
| NPH/Regular 70/30 Mix | 8.32 | ± 1.5 |
| Aspart Insulin Analog Biphasic Mix | 8.35 | ± 1.95 |
Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | NPH/Regular 70/30 Mix | Aspart Insulin Analog Biph… |
|---|---|---|---|
| Cardiovascular disease | Cardiac disorders | — | — |
| Cerebral vascular disease | Vascular disorders | — | — |
| Gastrointestinal | Gastrointestinal disorders | — | — |
| Genitourinary | Renal and urinary disorders | — | — |
| Hypoglycemia | Metabolism and nutrition disorders | — | — |
| Infection | Infections and infestations | — | — |
| Neurological disease | Nervous system disorders | — | — |
| Pulmonary disease | Respiratory, thoracic and mediastinal disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Surgery | Surgical and medical procedures | — | — |
| Adverse reaction | General disorders | — | — |
| Reaction | System | NPH/Regular 70/30 Mix | Aspart Insulin Analog Biph… |
|---|---|---|---|
| Severe Hypoglycemia | Metabolism and nutrition disorders | — | — |
Most-reported serious reactions: Cardiovascular disease, Cerebral vascular disease, Gastrointestinal, Genitourinary, Hypoglycemia, Infection, Neurological disease, Pulmonary disease.
Data from ClinicalTrials.gov NCT00821795 adverse events section.
Volunteers are being invited to take part in a research study about insulin therapy of diabetes. They are being invited to take part in this research study because they have diabetes and have an illness requiring hospitalization. If they volunteer to take part in this study, they will be one of about 120 people to do so. The investigators hope to answer the following research questions: * To show that insulin aspart protamine 70/30 mix taken twice daily is as good as insulin NPH/Reg 70/30 mix taken twice a day for treatment of diabetes after discharge from the hospital. * To show how safe the two medicines are (insulin aspart 70/30 mix vs. insulin NPH/Reg 70/30 mix) and how well they work for the treatment of diabetes when transitioning from inpatient therapy to outpatient care.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing