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NCT01267448 · ClinicalTrials.gov registry record · Phase 4
Outpatient Discharge Therapy With Saxagliptin+MetforminXR vs GlipizideXL for Type 2 Diabetes With Severe Hyperglycemia
A Phase 4 study, sponsored by Cook County Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
NCT01267448: Completed Phase 4 study, sponsored by Cook County Health.
NCT01267448 is a Phase 4 study that has completed, run by Cook County Health. The registered enrollment target is 100 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01267448, a Phase 4 study, has completed, sponsored by Cook County Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
Study Summary
Saxagliptin + Metformin XR (S+M) will be effective in stabilizing blood glucose (BG) levels in patients with newly diagnosed type 2 diabetes (T2DM) with severe hyperglycemia (BG levels 300 to 450 mg/dl) and glucose toxicity and with no criteria for inpatient admission or occurrence of severe hypoglycemia compared to glipizide XL. The study may provide preliminary evidence to support the role of S+M as a bridging, stabilizing and safe therapy in patients with severe hyperglycemia
Primary Outcome
Non-responder:1 FBG \>300 and/or PPBG \>400 mg/dl (week 1-6) and FBG \>250 and/or PPBG \>300 mg/dl in 4 consecutive readings or more (week 7-12). 2\. A single confirmed BG of \>450 mg/dl. 3. Significant hypoglycemia: Single episode of hypoglycemia with BG \< 50 mg/dl or 2 episodes of BG between 50 and 70 mg/dl within 7 days or any episode of symptomatic hypoglycemia. 4\. Persistently positive large ketones in urine and/or electrolyte imbalances. 5. Revisit to ED or admission to hospital becaus
Interventions
- DRUG Metformin XR
- DRUG Glipizide XL
- DRUG Saxagliptin + Metformin XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2014-09-09 |
| Est. Completion | 2015-07-25 |
| Phase | Phase 4 |
What the finished NCT01267448 record still lists
NCT01267448 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 3 interventions - of which Metformin XR is the first listed.
NCT01267448 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01267448 about?
NCT01267448 is a clinical study titled "Outpatient Discharge Therapy With Saxagliptin+MetforminXR vs GlipizideXL for Type 2 Diabetes With Severe Hyperglycemia". Saxagliptin + Metformin XR (S+M) will be effective in stabilizing blood glucose (BG) levels in patients with newly diagnosed type 2 diabetes (T2DM) with severe hyperglycemia (BG levels 300 to 450 mg/dl) and glucose toxicity and with no criteria for inpatient admission or occurrence of severe hypogly...
What is the current status of trial NCT01267448?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2014-09-09. Estimated completion is 2015-07-25.
What interventions are being tested in trial NCT01267448?
The interventions under investigation include: Metformin XR (DRUG), Glipizide XL (DRUG), Saxagliptin + Metformin XR (DRUG).
Who is sponsoring clinical trial NCT01267448?
This trial is sponsored by Cook County Health, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01267448's enrollment target sits among peer trials
100 770th of 2000 higher than 1,148 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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