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

NCT01267448 | Completed Phase 4 DMC

• 1 other identifier: IRB-10-182
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Diabetes Mellitus Type 2; Hyperglycemia

Keywords

Diabetes Mellitus Type2.; Hyperglycemia

Outcome Measures

Primary Outcomes (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). 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.

  12 weeks

Secondary Outcomes (4)

• Proportion of patients achieving FBG goal of 70-130 mg/dl at 12 weeks in the 2 treatment arms

  12 weeks

• Percentage of patients with symptomatic hypoglycemia

  12 weeks

• To measure percentage compliance with medication in the two treatment arms.

  12 weeks

• The number of fold increase in beta cell function in the 2 arms.

  12 weeks

Study Arms (2)

Saxagliptin + Metformin XR

ACTIVE COMPARATOR

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 goup Glipizide XL

ACTIVE COMPARATOR

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

Drug: Glipizide XL

Interventions

Glipizide XL DRUG

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

Also known as: Glucotrol XL

the Control goup Glipizide XL

Saxagliptin + Metformin XR DRUG

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

Also known as: Onglyza

Saxagliptin + Metformin XR

Metformin XR DRUG

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

Saxagliptin + Metformin XR

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Cook County Health: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

John Stroger Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia

Interventions

Glipizide; saxagliptin; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sulfonylurea Compounds; Sulfones; Sulfur Compounds; Organic Chemicals; Biguanides; Guanidines; Amidines

Study Officials

• Ambika Babu, MD,MS

  John H Stroger Hospital of Cook County

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: December 27, 2010
• First Posted: December 28, 2010
• Study Start: September 9, 2014
• Primary Completion: July 25, 2015
• Study Completion: July 25, 2015
• Last Updated: June 26, 2023

Record last verified: 2023-06

Locations

US (1)