A Phase 4 interventional study of Glipizide XL and Saxagliptin + Metformin XR in Diabetes Mellitus Type 2 and Hyperglycemia, sponsored by Cook County Health. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-06-26.
Sponsored by Cook County Health · Phase 4, Interventional, and Treatment
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
There is very little information regarding diabetes discharge regimens for patients with recently diagnosed diabetes (\<1 year duration) who present with severe hyperglycemia (blood glucose 300-450 mg/dl) to the ED or other clinical settings and who do not need to be admitted.
A combination of Saxagliptin+Metformin XR, could be a potential drug combination to be tested as an initial treatment in these circumstances compared to Glipizide XL which was shown to be effective in our previous study. We expect Saxagliptin to improve beta cell function and decrease glucagon levels as was shown for the DPP-IV class medications and in turn improve blood glucose levels, while Metformin XR may reduce insulin resistance and hepatic glucose output. Such discharge therapy may help to prevent deterioration into acute metabolic complications (DKA or hyperosmolar states) and avoid hospitalization. A high proportion of patients may achieve glycemic targets without significant hypoglycemia as measured by self glucose monitoring and objectively by continuous glucose monitoring system (CGMS). Such an easy regimen may safely bridge the time gap until patients will be seen by their providers.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Cook County Health is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Target Population
Age and Sex
WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours before the start of the investigational product.
Exclusion Criteria:
Sex and Reproductive Status
Target Disease Exceptions
Medical History and Concurrent Diseases
Physical and Laboratory Test Findings
Prohibited Treatments and/or Therapies
a)Treatment with systemic cytochrome P450 3A4 (CYP 3A4) inhibitors.
Other Exclusion Criteria
Saxagliptin 5 mg + Metformin XR 1000 mg will be automatically titrated weekly in 2 weeks to Saxagliptin 5 mg + Metformin XR 2000 daily for a total duration of 12 weeks.
Drug: Saxagliptin + Metformin XR · Drug: Metformin XR
The control group will receive Sulphonylurea (Glipizide XL 10mg orally) for a total duration of 12 weeks.
Drug: Glipizide XL
The control group will receive Glipizide XL (10mg orally) for a total duration of 12 weeks.
Also known as: Glucotrol XL
The intervention group will receive Saxagliptin 5 mg daily for a total duration of 12 weeks.
Also known as: Onglyza
The intervention group will receive Metformin XR 1000 mg daily and will be automatically titrated weekly in 2 weeks to Metformin XR 2000 daily for a total duration of 12 weeks.
Also known as: Glucophage XR
The proportion of responders in each arm. Responder: FBG 70-300 and/or PPBG <400 mg/dl (week1-6), FBG 70-250 and/or PPBG <300 mg/dl (week 7-12) and without metabolic exclusion criteria, repeat ED visits, hospitalization or significant hypoglycemia.
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 because of hypoglycemia or uncontrolled hyperglycemia.
Time frame: 12 weeks
Proportion of patients achieving FBG goal of 70-130 mg/dl at 12 weeks in the 2 treatment arms
The rate of decline in BG values (mg/dl) in the two groups over the period of twelve weeks will be analyzed using a mixed model (with random intercept) as a sensitivity analysis. The Kaplan-Meier (KM) curves, area under the curve,t-test and chi-square analysis will be used for analysis.
Time frame: 12 weeks
Percentage of patients with symptomatic hypoglycemia
Hypoglycemia and hospitalization rates will be compared between the 2 groups using either chi-square or Fisher exact test will be used. Binary logistic regression will be used to further analysis to identify predictors of hypoglycemia.
Time frame: 12 weeks
To measure percentage compliance with medication in the two treatment arms.
Medication compliance will be assessed by pill counting. Each patient will assigned a percentage compliance and the study groups will be compared using independent two sample t-test.
Time frame: 12 weeks
The number of fold increase in beta cell function in the 2 arms.
The early insulin response (EIR) will be calculated as the ratio of insulin to glucose response at 0 and 30 minutes (ΔI30pmol/l/ΔG30mmol/l,). The homeostasis model assessment to assess basal insulin secretion (HOMA-β cell) and insulin resistance (HOMA-IR) will be calculated. The beta cell response to OGTT will be calculated as area under the curve for glucose and insulin at 0, 30 and 60 minutes using the trapezoid rule.
Time frame: 12 weeks
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cook County Health