Phase 4 N=75 Randomized Treatment

Insulin Schemes for Type 2 Diabetes Control

Type 2 Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT03350984 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2020

Primary outcome: Primary: Differences in the Mean Daily Blood Glucose Between a Basal-bolus Scheme and NPH Schemes of Insulin. — 129.6; 135; 155.4; 156.2 mg/dl

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: NPH insulin (Drug); Glargine and Lispro insulin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Universidad de Guanajuato
Primary completion: Jul 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Differences in the Mean Daily Blood Glucose Between a Basal-bolus Scheme and NPH Schemes of Insulin.	129.6; 135; 155.4; 156.2; 127.4; 136.2	—
SECONDARY the Number of Participants With Mild and Severe Hypoglycemic Events	15; 15	—
SECONDARY Number of Participants With Sustained Glycemic Control During Hospital Stay	30; 20	—

Summary

The aim of the study is to determine differences in glycemic control between a basal-bolus scheme insulin and NPH scheme insulin in a population of hospitalized patients with type 2 diabetes in a Noncritical Care Facility in Mexico. Patients with a recent diagnosis of type 2 and patients on treatment with oral hypoglycaemic agents and insulin or only insulin were included. The primary outcome of the study is to determine difference in efficacy and security between a basal-bolus scheme insulin and NPH scheme insulin in patients with type 2 diabetes hospitalized in non-critical areas in a hospital in Mexico

Eligibility Criteria

Inclusion Criteria

Patients between 18 and 100 years old.
History of type 2 diabetes mellitus (DM2) or that upon admission is diagnosed by values of glycated haemoglobin (HbA1) > 6.5%
Fasting central glucose before randomization between 140mg/dl and 400mg/dl
Non-critical patients hospitalized in the service of Internal Medicine (MI), General Surgery (CG) and Traumatology (TyO).
Patients receiving a diabetic diet orally
Treated with diet alone, o any combination of oral anti-diabetic agents or insulin treatment with any dosage before admission.

Exclusion Criteria

Parenteral nutrition
Hyperglycemia without a known history of diabetes
Impaired renal function (glomerular filtration rate less than 30)
Diabetic ketoacidosis and hyperosmolar state
Type 1 Diabetes mellitus
Pregnancy
Patients on treatment with more than 10mg prednisone or steroid boluses.
Known hypopituitarism or adrenal insufficiency
Hyperglycaemia due to stress (negative antecedent of DM2, hyperglycemia and HbA1 <6.5)
Severe liver disease (Child-Pugh C score)
Acute pancreatitis
Patients with sepsis or multiple organ failure
Candidates for intensive care unit

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03350984). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.