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Diabetes Mellitus Type 2Phase 4NCT01267448

Outpatient Discharge Therapy With Saxagliptin+MetforminXR vs GlipizideXL for Type 2 Diabetes With Severe Hyperglycemia

A Phase 4 study testing Glipizide XL, Saxagliptin + Metformin XR and Metformin XR in people with Diabetes Mellitus Type 2 and Hyperglycemia, run by Cook County Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus Type 2, Hyperglycemia
What is being tested?
Glipizide XL, Saxagliptin + Metformin XR and Metformin XR
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
9 Sep 2014to 25 Jul 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Target Population
  • Subjects recently diagnosed with T2DM (less than 1 year duration) who are either drug naïve or who had not taken oral anti-diabetic agents or insulin for more than 2 weeks.
  • FBG and or RBG > 300mg/dl and < 450mg/dl
  • Age and Sex
  • Men and women aged 18 to 75 years of age.
  • Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study drug to minimize the risk of pregnancy.
  • 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.

Who cannot join

  • Sex and Reproductive Status
  • WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the last dose of study drug.
  • Women who are pregnant or breastfeeding.
  • Women with a positive pregnancy test.
  • Sexually active fertile men not using effective birth control if their partners are WOCBP.
  • Target Disease Exceptions
Show all 27Show fewer
  • Type 2 diabetes with weight less than 120 pounds
  • Type 1 diabetes
  • History of diabetic ketoacidosis or hyperosmolar nonketotic coma
  • Medical History and Concurrent Diseases
  • Age >75 years
  • History of congestive heart failure
  • Evidence of an impaired sensorium and/or dementia
  • Current history of alcohol or substance abuse
  • Patients with any acute or active chronic medical illness
  • Physical and Laboratory Test Findings
  • FBG and /or RGB < 300 mg/dl or >450 mg/dl
  • Unstable vitals signs (temperature >101 degrees Fahrenheit, systolic blood pressure <90 or >180 mmhg, diastolic blood pressure <60 or >110 mmhg, heart rate <60 or >120 beats/minute)
  • Electrolyte imbalances (serum bicarbonate level <20 mEq/L, serum sodium <125 or >150 mEq/L, serum potassium <3.5 or >5.5 mEq/L), serum creatinine more than 1.5 in males and 1.4 in females, creatinine clearance less than 60ml/min, liver enzymes 3 times above upper limit of normal range.
  • HbA1c > 12% (based on our previous study (4) patients with HbA1c of >12 had a high rate of non-responders)
  • Liver enzymes 3 times above upper limit of normal range.
  • Allergies and Adverse Drug Reactions -Subjects with a history of any serious hypersensitivity reaction to saxagliptin, glipizide or metformin XR.
  • Prohibited Treatments and/or Therapies
  • a)Treatment with systemic cytochrome P450 3A4 (CYP 3A4) inhibitors.
  • Other Exclusion Criteria
  • Prisoners or subjects who are involuntarily incarcerated.
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • John Stroger Hospital of Cook County

    Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: A Pilot Study of Outpatient Discharge Therapy With Saxagliptin + Metformin XR or Sulphonylurea for Recently Diagnosed Type 2 Diabetes Presenting 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 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

Read the detailed description

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.

Being tested
Glipizide XL, Saxagliptin + Metformin XR, Metformin XR
Keywords
Diabetes Mellitus Type2., Hyperglycemia
Medical subject headings
Diabetes Mellitus, Type 2, Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Glipizide XLDrug

    Also called Glucotrol XL

    The control group will receive Glipizide XL (10mg orally) for a total duration of 12 weeks.

  • Saxagliptin + Metformin XRDrug

    Also called Onglyza

    The intervention group will receive Saxagliptin 5 mg daily for a total duration of 12 weeks.

  • Metformin XRDrug

    Also called Glucophage XR

    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.

Study groups in NCT01267448
Study groupRoleWhat they receive
Saxagliptin + Metformin XRActive comparatorSaxagliptin 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.
Receives: Drug: Saxagliptin + Metformin XR; Drug: Metformin XR
the Control goup Glipizide XLActive comparatorThe control group will receive Sulphonylurea (Glipizide XL 10mg orally) for a total duration of 12 weeks.
Receives: Drug: Glipizide XL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    1. 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.
    2. Persistently positive large ketones in urine and/or electrolyte imbalances. 5. Revisit to ED or admission to hospital because of hypoglycemia or uncontrolled hyperglycemia.

    Measured: 12 weeks

Secondary outcomes (4)

  1. 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.

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

  3. 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.

    Measured: 12 weeks

  4. 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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2010 (estimated)
  2. Study start9 Sep 2014
  3. Primary completion25 Jul 2015
  4. Study completion25 Jul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01267448
Sponsor's protocol ID
IRB-10-182
Status last verified
Jun 2023
First submitted
27 Dec 2010
Last updated
26 Jun 2023
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Glipizide XL, Saxagliptin + Metformin XR and Metformin XR in people with Diabetes Mellitus Type 2 and Hyperglycemia, run by Cook County Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01267448.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.

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